SAFETY DATA SHEET (SDS)

(1)

SAFETY DATA SHEET (SDS)

SDSen25256 Rev. A (May 2016) Page 1 of 19

SECTION 1: IDENTIFICATION OF PRODUCT (MIXTURE) AND SUPPLIER

Product Name: GS HIV-1/HIV-2 PLUS O EIA

Human Immunodeficiency Virus Types 1 and 2 (Recombinant and Synthetic Peptides) Product Number: 25256 (4800 tests)

Catalog number(s) for replacement, optional and separately purchased components that can be obtained for use with this kit, and which are covered by this SDS include: 25117, 25118, 25119, 25120, 25121, 25122, 25123, 26181 and 26182 (refer to Section 2).

Intended Use: The GS HIV-1/HIV-2 PLUS O EIA is an enzyme immunoassay utilizing recombinant proteins and synthetic peptides for the detection of antibodies to HIV-1 (Groups M and O) and/or HIV-2 in human serum and plasma. It is indicated as a screening test for specimens from individual human donors, including donors of whole blood, blood components, and source plasma, and from other living donors.

It is also intended for use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors. In addition, it is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2. The assay is not intended for use on cord blood specimens.

The GS HIV-1/HIV-2 PLUS O EIA is intended for manual use and also for use with the ORTHO^® Summit^® System (OSS) in the screening of blood donors.

The GS HIV-1/HIV-2 PLUS O EIA is intended for manual use and also for use with the EVOLIS™

Automated Microplate System as an aid in the diagnosis of infection with HIV-1 and/or HIV-2.

Manufactured by: Bio-Rad Laboratories, Inc.

Address: 6565 185th Avenue NE

Redmond, WA 98052-5039, USA Website: www.bio-rad.com

Phone Number: 1-800-2-BIORAD (1-800-224-6723); or 1-425-881-8300 (daytime PT) SDS e-mail contact: [email protected]

Technical Information

Contacts: Bio-Rad provides a toll free line for technical assistance, available 24 hours a day, 7 days a week. In the United States of America and Puerto Rico, call toll free 1-800-2-BIORAD (1-800-224-6723).

Outside the U.S.A., please contact your regional Bio-Rad office for assistance. Refer to section 16 for non-US local Bio-Rad agent contact information.

Authorized

Representative in the European

Community:

FRANCE: Bio-Rad

3 boulevard Raymond Poincaré 92430 Marnes-la-Coquette

Phone: +33 (0) 1 47 95 60 00 / Fax: +33 (0) 1 47 41 91 33 [[email protected]]

Emergency Phone

Number: This SDS is listed with CHEMTREC 1-800-424-9300 (US) / 001-703-527-3887 (international – can be called collect). Use only in the event of a CHEMICAL EMERGENCY involving a SPILL, LEAK, FIRE, EXPLOSION or ACCIDENT with this product.

SECTION 2:HAZARDS IDENTIFICATION -- HAZARDOUS COMPONENTS

This test kit should be handled only by qualified personnel trained in laboratory procedures and familiar with their potential hazards.

Specific warnings are given in the instructions for use. The absence of a specific warning should not be interpreted as an indication of safety. The following information is furnished for those product hazardous constituents that require regulatory control or disclosure at the concentration found in the product. Refer to Section 16 for the full text of any solely abbreviated or coded hazard statements provided below and for the Key / legend to abbreviations and acronyms.

Component ^* Content

R1. HIV-1/HIV-2 PLUS O Microwell Strip Plate

50 plates

- Microwell plate with adsorbed purified HIV-1 and HIV-2 antigens (Recombinant and Synthetic Peptide).

- Potential residue of ProClin 150 used as a production preservative (aspirated prior to drying strips).

- Tabs are labeled “BB”

- Contains sealed pelletized desiccant packet(s): There are no health hazards associated with intact desiccant container; however, health hazards could result from dusts generated if the packet is cut, split or otherwise compromised and is crushed.

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SDS

R3.

C0.

C1.

C2.

C3.

R4.

R5.

Sen25256 Rev. A (

Componen . Specimen Di

5 bottles (100 Catalog No. 2

WARNING . Negative Con 5 vials (8 mL Catalog No. 2

. HIV-1 Positi Control 10 vials (1.4 m Catalog No. 2

. HIV-2 Positi Control 10 vials (1.4 m Catalog No. 2

. HIV-1 Group Positive Con 10 vials (1.4 m Catalog No. 2

. Conjugate Concentrate 5 vials (12 mL Catalog No. 2

WARNING . Conjugate D

5 bottles (120 Catalog No. 2

WARNING

(May 2016)

nt ^* iluent 0 mL) 25123

G

- B - Pr

8 P

ntrol L)

25117 - H - Pr o g - Pr U c ive

mL) 25118

- H - Pr o g - Pr U c ive

mL) 25119

- H - Pr o g - Pr U c p O

ntrol mL) 25120

- R a - Pr o g - Pr U c

(11X) L) 25122

G

- Pu c Pre 8 P - Pr U c Diluent,

0 mL) 25121

G

- B l - Pr

8 P

GS H

Buffer (pH neutra reserved with 0.

84-9. GHS \ US P333 + P313; P5

Heat-treated hum reserved with 0.

one (C4H5NOS);

global GHS-base reserved with 0.

US HCS, EC CL concentration.

one (C4H5NOS);

Rabbit serum con and HCV antibod

reserved with 0.

one (C4H5NOS);

urified HIV-1 an caprine) and gree eserved with 0.5 84-9 [GHS \ US P333 + P313; P5 reserved with 0.

Buffer with prote iquid].

reserved with 0.

84-9. GHS \ US P333 + P313; P5

HIV-1/HIV

al) with protein s 1% ProClin 30

HCS \ EC CLP 501.

man serum/plasm 16% ProClin 9 CAS# 2682-20 ed regulatory req

005% gentamic LP and analogous

005% gentamic LP and analogous ntaining HIV-1 G dies and HBsAg 16% ProClin 9 CAS# 2682-20 ed regulatory req

005% gentamic LP and analogous nd HIV-2 antige en dye (food gra

% ProClin 300 HCS \ EC CLP 501.].

ein stabilizers (b 1% ProClin 30 HCS \ EC CLP 501.

V-2 PLUS

stabilizers, bovin 00 (0.003% activ

Classification: W

a containing HIV 950 containing 0.

-4, EC No 220-2 quirements in thi cin sulfate, CAS s global GHS-ba

-4, EC No 220-2 quirements in thi cin sulfate, CAS s global GHS-ba Group O antibod g.

950 containing 0.

-4, EC No 220-2 quirements in thi cin sulfate, CAS s global GHS-ba ns labeled with p ade).

(0.015% active Classification: W cin sulfate, CAS s global GHS-ba

bovine) and glyce 00 (0.003% activ

Classification: W

S O EIA

Content ne proteins and s ve ingredient), EC

WARNING; GH

V-2 antibody, no .016% active ing 239-6. Not subj is product mixtu S# 1405-41-0, E ased regulatory r

V-1 antibody, no .016% active ing 239-6. Not subj is product mixtu S# 1405-41-0, E ased regulatory r

V-2 antibody, no .016% active ing 239-6. Not subj is product mixtu S# 1405-41-0, E ased regulatory r dy diluted in norm

.016% active ing 239-6. Not subj is product mixtu S# 1405-41-0, E ased regulatory r peroxidase in a b

ingredient), EC WARNING; GH S# 1405-41-0, E ased regulatory r

erol (CAS#: 56- ve ingredient), EC

WARNING; GH

sample indicator C Index No 613 HS07; H317; P2

on-reactive for H gredient: 9.5-9.9 ect to GHS, US ure and concentra EC No 215-778-9 requirements in

on-reactive for H gredient: 9.5-9.9 ect to GHS, US ure and concentra EC No 215-778-9 requirements in mal human serum gredient: 9.5-9.9 ect to GHS, US ure and concentra EC No 215-778-9 requirements in buffer with prot C Index No 613-1

HS07; H317; P28 EC No 215-778-9 requirements in

-81-5, EC No 20 C Index No 613 HS07; H317; P2

[Cat

P r dye (< 0.1%, d -167-00-5 with 80; P302 + P352

HBsAg and antib 9% 2-methyl-4-i

HCS, EC CLP a ation.

9. Not subject to this product mix

9. Not subject to this product mix m/plasma; negat 9% 2-methyl-4-i

9. Not subject to this product mix ein stabilizers (b 167-00-5 with C 80; P302 + P352 9. Not subject to

this product mix

00-289-5) [pH ne -167-00-5 with 80; P302 + P352

talog # 25256]

Page 2 of 19 dark purple).

CAS# 55965- 2,

body to HCV.

sothiazolin-3- and analogous o GHS, xture and

body to HCV.

tive for HIV sothiazolin-3- and analogous o GHS, xture and bovine and CAS# 55965-

2, o GHS, xture and

eutral, clear CAS# 55965- 2,

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SDS

R8.

R9.

*

Ma

Sen25256 Rev. A (

Componen . Substrate Bu 5 bottles (120 Catalog No. 2

. Chromogen 5 bottles (12 m Catalog No. 2

Replacement, com

arkings accor Communicat GHS-based g This product United States guidelines an concentration Component R

Comprehens

Label(s):

Signal Wor Label Haza

H317 Precautiona

P280 P302 + P P333 + P P501 Supplemen

P261 P272 [Source: Raw M

(May 2016)

nt ^* uffer, 0 mL) 26181

- D l - <

- <

No p (11X)

mL) 26182

- ≤ E - ≤ l t mponent Catalog n

rding to the tion Standard global regulat has been con s Hazard Com nd applicable ns are found in R3, and R5 - 0.1 chloro-2-m isothiazol- CAS# 559 sive GHS Based

rd:

ard Statements:

May cause ary Statements (

W

P352 I

P313 I

D ntal Precautionar

A C Material vendor

GS H

Dilute citric acid iquid].

5% dimethylsu 0.1% hydrogen ot subject to GH product mixture

0.25% 3,3’,5,5 EC No 264-769- 0.04 N hydroc iquid). Not subj his product mixt numbers are provid

United Nati d (US HCS), E

ions:

nservatively cl mmunication St e analogous G product compo

% ProClin 300 methyl-4-isothiaz 3-one (C4H5N 65-84-9.

d Classification:

WARNING

e an allergic ski (statements for p Wear protective IF ON SKIN: W If skin irritation Dispose of conte ry Statements (ad Avoid breathing Contaminated w r SDS, CCOHS d

HIV-1/HIV

d (C6H8O7, CAS#

ulfoxide [DMSO n peroxide [H2O HS, US HCS, E and concentratio

’ tetramethylbe 6.

chloric acid [~

ject to GHS, US ture and concent ded in this column

ions (UN) G European Com assified and la tandard (US H GHS-based glo

onent(s):

0 or Component zolin-3-one (C4

NOS; CAS# 26 : Skin Sen

in reaction.

product intended gloves / protecti Wash with plenty or rash occurs: G ents and containe

dditional precau mist / vapors/va ork clothing sho databases and re

V-2 PLUS

# 79-92-9, EC N O - C2H6OS], CA O2], CAS# 7722- EC CLP and an on.

enzidine dihydr

~ 0.3% HCl, CA S HCS, EC CLP

tration.

where available.

Globally Harm mmunity (EC) 2

abeled in acco HCS), related E obal regulatio

t R4 - 0.5% Pro

4H4ClNOS; CA 682-20-4, EC nsitizer Categor

d use and as codif ive clothing / ey

of soap and wat Get medical adv er in accordance utions to conside apours / spray.

ould not be allow egulatory resear

S O EIA

Content No 201-069-1) / s

AS# 67-68-5, EC -84-1, EC No 23 nalogous global

rochloride [TMB AS# 7647-01-0,

and analogous

monized Syst 2008/1272/EC ordance with a European Com ons. The follo

oClin 300 [≤ 0.0 AS# 26172-55-4 No 220-239-6) ry 1

ified on the prod ye protection / fa

ter.

vice/ attention.

e to local, region er relative to spe

wed out of the wo rch]

sodium acetate C No 200-644-3.

31-765-0.

GHS-based reg

B– C16H20N2•2H EC No 231-595 global GHS-bas

tem (GHS), C (EC CLP) gu

applicable Un mmunity (EC) 2

owing regulat

015%. active ing 4, EC No 247-5

(3:1)], EC I

duct label):

ace protection.

nal, national and ecific customer u

orkplace.

[Cat

P buffer, [pH ~ 4

.

gulatory require

HCl], CAS# 207 5-7] solution (p sed regulatory re

United State uidelines and ited Nations ( 2008/1272/EC ted hazardous

gredients – reacti 500-7) and 2 Index No 613-16

international reg use):

talog # 25256]

Page 3 of 19 4.0, clear

ements in this

738-08-7, H ~ 1.5, clear equirements in

es Hazard analogous (UN) GHS, C (EC CLP) s chemical

ion mass of: 5- 2-methyl-2H -

67-00-5 with

gulations.

(4)

GS HIV-1/HIV-2 PLUS O EIA

[Catalog # 25256]

SECTION 3: COMPOSITION/INFORMATION ON INGREDIENTS

The following information is furnished for those product hazardous constituents that require regulatory control or disclosure regardless of the concentration found in the product. Note that the information here is often based on data from the chemical raw material safety data sheet and literature (LD50, exposure limits, etc.) Chemical constituents that do not require regulatory disclosure are not generally included here. This product contains a significantly diluted concentration in an aqueous solution, thus the assessment below has not considered the dilution reduction effect on the hazard. That hazard communication information is provided in Section 2 above. Some components were tested at the concentration found in the kit. In that case, the assessment is provided for the chemical dilution tested and the tested concentration will be provided at the beginning of the Chemical Ingredient Data/Information box. Refer to section 16 for the full text of any Comprehensive GHS-based Classification statements coded below, for the list of sources utilized in the assessment and for the Key / legend to abbreviations and acronyms.

Chemical Ingredient Data / Information Chemical Ingredient: Dimethyl-sulfoxide [DMSO]

Chemical concentrations found in this product: ≤ 5 % in R8, an aqueous solution Data for Concentrated / 100% chemical used in the product mixture (concentration tested):

CAS#: 67-68-5 (100%) LD50 (oral-rat): 14500 mg/kg (100%)

EC No: 200-644-3 (100%) LC50 (inhalation-rat): 1600 mg/m³ (4 hr) (100%) RTECS#: PV6210000 (100%) LD50 (skin-rabbit): >5000 mg/m³ (100%)

Index No: NA (100%) LC50 (96 hr-fish): NE mg/L (100%)

Chemical Formula: C2H6OS (100%) Flash point: 188-192°F / 86.7-88.9°C (100%)

Molecular weight: 78.13 g/mol (100%) Flammable limits: LEL/LFL is 3.5%; UEL/UFL is 42% vv in air (100%) Synonyms/Trade Names: Dimethyl sulfoxide; Dimethyl sulphoxide; Dimexide; Dipirartril-tropico; DMS-70; DMS-90; DMSO; Dolicur;

Domoso; Dromisol; Durasorb; A 10846; Deltan; Demeso; Demasorb; Demavet; Demsodrox; Dermasorb; Gamasol 90; Hyadur;

Infiltrina; M 176, Methane, sulfinylbis-; Methylsulfinylmethane; Somipront; SQ 9453, Topsym; NSC-763; Rimso-50;

Sulfinylbis(methane); Syntexan

Raw Material GHS / US HCS / EC CLP Classification (100%): No Pictogram required WARNING

Fla. Liq. Cat. 4 H227

P210, P280, P370 + P378, P403 + P235, P501

[Source: Raw Material vendor SDS, CCOHS databases and regulatory research]

Chemical Ingredient: Glycerol

Chemical concentrations found in this product: ≤ 4% in R5 Data for Concentrated / 100% chemical used in the product mixture (concentration tested):

CAS#: 56-81-5 (100%) LD₅₀ (oral-rat): 12,600 mg/kg (100%)

EC No: 200-289-5 (100%) LC50 (inhalation-rat): > 570 mg/m³/1H (100%) RTECS#: MA8050000 (100%) LD50 (skin-rabbit): > 10000 mg/kg (100%)

Index No: NA (100%) LC50 (96 hr-fish): NE (100%)

Chemical Formula: C3H8O3 (100%) Flash Point: 320 F / 160° C (100%)

Molecular weight: 92.09 g/mol (100%) Flammable limits: LEL/LFL is 0.9% vv in air.

Synonyms/Trade Names: 1,2,3-Propanetriol; 1,2,3-Trihydroxypropane; 90 Technical glycerine; Citifluor AF 2; lyzerin, wasserfrei, Glycerin;

Glycerin mist; Glycerin mist; Glycerin, anhydrous; Glycerin, synthetic; Glycerine; Glyceritol; Glycyl alcohol; Grocolene; MOON;

Osmoglyn; Star; Synthetic glycerin; Trihydroxypropane

Raw Material GHS / US HCS / EC CLP Classification (100%): Not a dangerous substance according to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements.

[Source: Raw Material vendor SDS, CCOHS databases and regulatory research]

(5)

SDS Ch

Da C E R I T C M

R

Ra W A H P [So Ch

Ha

Da R

p F L L L L

R Ra

D A H P

Sen25256 Rev. A ( hemical Ingredi

ata for Concentr CAS#: 77-92-9 EC No: 201-069 RTECS#: GE73 Index No: NA ( Toxicity to fish Chemical Formu Molecular weigh Synonyms/Trad

Hydroxytr Skin corrosion/i Serious eye dam Respiratory or s

aw Material GHS WARNING Acute Tox. – skn H313, H316, H3 P264, P280, P30 ource: Raw Mate hemical Ingred

azardous ingredi 60-100% Glyco 1-5% Mixture ( and 2-Meth CAS#: 559 Index No: 6 ata for chemical

RTECS#: NE Synonyms/Trad

solution pH value: 4.1 at Flash Point: 244 LD50 (oral-rat): 8 LD₅₀ (skin-rabbi

LC50 (inhalation LD₅₀ (skin-rabb Skin corrosion/i Serious eye dam Respiratory or s aw Material GHS

DANGER!

Acute Tox. – ora H302, H314, H3 P261, P264, P27 P303 + P36 [Source: Raw M

(May 2016) ent: Citric acid

Chemica rated / 100% ch (100%) 9-1 (100%)

50000 (100%) 100%)

mortality LC50 - ula: C6H8O7 (100 ht: 192.12 g/mol e Names: Acilet ricarballylic acid

rritation: Skin - mage/eye irritatio kin sensitization

HS / US HCS / EC n Cat. 5, Skin Ir 319

05 + P351 + P33 erial vendor SDS dient: ProClin Chemic ent concentratio ols;

(3:1) of 5-Chlor hyl-2H -isothiaz 965-84-9

613-167-00-5 l used in the pro

e Names: Synon 100 g/L (concen 4° F / 118° C (co

862 mg/kg (conc it): 2,800 mg/kg n-rat): NE

it): NE rritation - rabbit mage/eye irritatio kin sensitization HS / US HCS / EC

al Cat. 4, Skin C 317, H410 70, P272, P273, 61 + P353, P305

Material vendor

GS H

C d

al concentrations hemical used in

- Leuciscus idus 0%)

l (100%) tten; Anhydrou d; Kyselina citro

rabbit - Mild ski on: Eyes - rabbit n: Prolonged or r

C CLP Classific

rit. Cat. 1, Eye I 38, P337 + P313 S, CCOHS datab n 300

cal concentratio n in raw materia ro-2-methyl-4-is zol-3-one (C4H4

oduct (concentra nyms/Trade Na

ntrated solution) oncentrated solut centrated solutio (concentrated so

t – Corrosive (co on - rabbit - Corr n - May cause all C CLP Classific

Corr. Cat. 1B, Ey P280, P301 + P3

+ P351 + P338 SDS, CCOHS d

HIV-1/HIV

Chemical Ingre

s found in this pr n the product m

LD50 ( LC50 ( LD50 ( melanotus - 440 pH val us citric acid onova

in irritation - OE - Irritating to ey repeated exposur

cation (100%):

Irrit. Cat. 2A

bases and regula ons found in th

≤ al:

sothiazolin-3-on ClNOS; CAS# 2

ation tested):

mes: 5-Chloro-2 )

tion) on)

olution)

oncentrated solut rosive to eyes (co

lergic skin reacti cation (100%):

ye Damage.1, Sk 312 + P330, P30 + P310, P333 + databases and re

V-2 PLUS

edient Data / I

roduct: <.1.5%

ixture (concentr (oral-rat): 5400 m (inhalation-rat): N (skin-rabbit): >2 0 mg/l - 48 h Me lue: 1.8 at ca.50 d; Citretten;

ECD Test Guide yes. - OECD Tes re may cause all

atory research]

his product: 0.5

≤ 0.1% (≤ 0.00

ne (C4H5NOS; C 26172-55-4, EC#

2-methyl-4-isoth

tion)

oncentrated solu ion (concentrate

kin. Sens. Cat.1, 01 + P330 + P33 P313, P363, P3 egulatory researc

S O EIA

Information

w/v in R8 ration tested):

mg/kg NE 000 mg/kg ethod: OECD Te

g/l at 25 °C (77 Citro; 2-Hydr line 404 st Guideline 405 lergic reactions i

5% (0.015% a 03% active in

CAS# 2682-20-4

# 247-500-7)

hiazolin-3-one so

ution) ed solution)

Aquatic Acute C 31,

391, P405, P501 ch]

est Guideline 203 7 °F)

roxy-1,2,3-propa

5

in certain sensiti

active ingredie gredient) in R

4, EC# 220-239-

olution; Kathon

Cat. 1, Aquatic C

[Cat

P 3

anetricarboxylic

ve individuals.

ent) in R4 R3 and R5

-6)

300; Isothiazolin

Chronic Cat. 1

talog # 25256]

Page 5 of 19 acid; beta-

none chloride

(6)

SDS

Ch Da

C E I R C M S L S S I Ra D H P

Ch

Da C E R C M

Ra a [

Sen25256 Rev. A (

hemical Ingred ata for Concentr CAS#: 7647-01- EC No: 231-595 Index No: 017-0 RTECS#: MW4 Chemical Formu Molecular weigh Synonyms/Trade Chlorowodor LC₅₀ (male rat):

LC50 (male ra Skin corrosion/ir Serious eye dam IARC: Group 3:

aw Material GHS DANGER!

Skin Corr. Cat.

H290, H314, H3 P234, P261, P26 P305 + P35 [Source: Raw M hemical Ingred

ata for Concentr CAS#: 207738-0 EC No: 264-769 RTECS#: DV23 Chemical Formu Molecular weigh Synonyms/Trad aw Material GHS

analogous globa [Source: Raw M

(May 2016)

dient: Hydroc Chemic rated / 100% ch -0 (concentrate s 5-7 (concentrate 002-01-X (conce 4025000 (concen ula: HCl (concen ht: 36.46 g/mol ( e Names: Acide

; Chlorwassersto 1405 ppm (4-ho at): 1562 ppm (4

rritation: Skin - mage/eye irritatio Not classifiable HS / US HCS / EC

1B, Eye Damage 335

64, P271, P280, 51 + P338, P310 Material vendor dient: 3,3’,5,5 Chemic rated / 100% ch 08-7 (54827-17- 9-6 (100%) 300000 (100%)

ula: C16H20N2•2H ht: 313.27 g/mol e Names: TMB HS / US HCS / EC

al GHS-based reg Material vendor S

GS H

C chloric acid cal concentratio

hemical used in solution)

solution) entrate solution) ntrate solution)

ntrate solution) (concentrate solu

chlorhydrique;

off; Hydrochlori our exposure; he -hour exposure;

rabbit - Causes b on: Eyes - rabbit

e as to its carcino C CLP Classific

e Cat. 1, STOT P301 + P330 + P , P363, P390, P4 r SDS, CCOHS d

’-Tetramethy cal concentratio

hemical used in -7 Free base) (10

HCl (100%) l (100%)

C CLP Classific gulatory requirem SDS, CCOHS da

HIV-1/HIV

Chemical Ingre

ons found in th n the product m

ution) pH val

; Acido cloridr de; Hydrogen ch ead-only); cited a whole-body); ci burns. (30-50%

- Corrosive to e ogenicity to hum cation (100%):

SE Cat. 3, Met P331, P303 + P3 403 + P233, P40 databases and re ylbenzidine, Di ons found in th n the product m

00%)

cation (100%): N ments.

atabases and reg

V-2 PLUS

edient Data / I

his product: ≤ 0 ixture (concentr LD LC LD Fi lue: highly acidi rico; Anhydrou hloride; Hydroge as 2810 ppm (1-h ited as 3124 ppm

solution) yes (30-50% sol mans (30-50% so

t. Corr. Cat. 1 361 + P353, P30 05, P406, P501 egulatory resear

ihydrochlorid his product: < 0

ixture (concentr LD LD LC LD LC

Not a dangerous gulatory research

S O EIA

Information

0.04N (< 0.4%

ration tested):

D50 (oral, rat): 70 C50 (inhalation-r D50 (skin-rabbit) sh LC50 – Blueg ic (30-50% conc us hydrochloric en chloride; Mur

hour exposure; h m (1-hour exposu

lution) olution)

04 + P340, rch]

de

0.3% w/v in R ration tested):

D50 (ipr-mouse):

D50 (oral-rat): NE C50 (inhalation-r D50 (skin-rabbit) C₅₀ (96 hr-fish):

substance accor h]

% v/v HCl) in R 00 mg/kg (uncon rat): 3124 ppm/1 ): Greater than 5 gill/Sunfish – 28 centrated solution c acid; Chloorw riatic acid; Spiri head-only) (30-5 ure; whole-body

R9

: 135 mg/kg (100 E

rat): NE ): NE

NE (100%)

rding to GHS, U

[Cat

P

R9 nfirmed)

H

010 mg/kg (unc 2 mg/l – 48 h n)

waterstof; Chlo its of salt 50% solution) y) (30-50% solut

0%)

US HCS, EC CLP

talog # 25256]

Page 6 of 19 onfirmed)

orohydric acid;

tion)

P and

(7)

SDS

Ch Da

H C E R C

Ra D A H P [ Ch

Da C E R

Ra D R H P [

Sen25256 Rev. A (

hemical Ingred ata for chemical

Hazardous ingre 5-10% of 2-m CAS#: 2682-20- EC No: 220-239 RTECS#: NE Chemical Formu

aw Material GHS DANGER!

Acute Tox. -- in H314, H317, H3 P261, , P264, P2 P305 + P35 [Source: Raw M hemical Ingredi

ata for chemical CAS#: 1405-41- EC No: 215-778 RTECS#: LY26 Synonyms/Trad aw Material GHS

DANGER!

Resp. Sens., Cat H317, H334 P261, P272, P28 [Source: Raw M

(May 2016)

dient: ProClin Chemic l used in the pro edient concentrat methyl-4-isothiaz -4 (active ingred 9-6 (active ingred ula: C4H5NOS (a HS / US HCS / EC

nhl. Cat. 3, Skin C 331, H400 271, P272, P273 51 + P338, P310 Material vendor S

ent: Gentamici Chemica l used in the pro -0 (100%) 8-9 (100%) 625000 (100%)

e Names: Genta HS / US HCS / EC

t. 1, Skin Sens., 80, P285, P302 + Material vendor S

GS H

C n 950

cal concentratio oduct (concentra tion in raw mate zolin-3-one (activ dient)

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ons found in th ation tested):

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cation (100%):

Eye Damage Cat.

P330 + P331, P3 P405, P501 atabases and reg

s found in this pr ation tested):

lt; Garamycin; G cation (10%):

P341, P333 + P atabases and reg

V-2 PLUS

edient Data / I

his product: ≤ trated preservati LD50 (oral- LC50 (inhal LD50 (skin- pH value: 3

. 1, Skin Sens. C

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LD50 (o LC₅₀ (in LD50 (s Gentiomycin C

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Information

0.16% in C0, ive contains:

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353, h]

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Acute Cat. 1, Aqu

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[Cat

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C0, C1, C2, C3 50 mg/ml)

talog # 25256]

Page 7 of 19 ution) on)

at. 1

3 and R4

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GS HIV-1/HIV-2 PLUS O EIA

[Catalog # 25256]

Biological Ingredient Data / Information

Human Source Material [reactive and non- reactive]

The positive controls (C1 and C2) were heat-treated to inactivate the HIV. Human sera / plasma in reagents were tested and found non-reactive for HBsAg and antibodies to HCV (Component C0 and C3 are also non-reactive for antibodies to HIV-1/HIV-2).

No known test method can offer complete assurance that HIV, hepatitis B or C virus or other infectious agents are absent. Moreover, patient blood samples tested with this kit represent an unknown, heightened hazard. Employ Standard and Universal Precautions when handling these reagents and all human blood or specimens. Handle as if capable of transmitting infectious disease, in a Biosafety Level 2 lab, applying the guidelines from the current CDC/NIH Biosafety in Microbiological and Biomedical Laboratories or WHO Laboratory Biosafety Manual. Avoid splashing, spills and the generation of aerosols. Secure in secondary containment with proper biohazard labeling. Do not inhale mists or aerosols; avoid contact with skin, eyes, mucous membranes and clothing. In case of contact with eyes, immediately rinse with copious water and seek medical attention. Employ decontamination procedures with appropriate decon agent or disinfectant (typically a 1:10 dilution of household bleach, 70-80% ethanol or isopropanol, an iodophor like 0.5% Wescodyne Plus (EPA Reg. #4959-16), an o-phenylphenol/amyphenol such as 0.8%

Vesphene (EPA Reg. #1043-87), or equiv.) before discarding any materials utilized or returning equipment used to general use. Dispose of this material in accordance with local, regional, national and international regulations. Handle appropriately with the requisite Good Laboratory Practices, Standard and Universal Precautions.

Persons handling blood samples should have the option of receiving hepatitis B vaccination.

Animal proteins [components C3, R3, R4, R5]

This material is of animal origin (bovine, caprine [goat], rabbit, etc.) and may be a potential contact irritant. Hazard Unknown. Handle as potentially infectious. The chemical, physical and toxicological properties have not been thoroughly investigated. Handle appropriately with the requisite Good Laboratory Practices, Standard and Universal Precautions. Dispose of this material in accordance with local, regional, national and international regulation.

NA: Not Applicable.

NE: Not Established or Unknown (unable to locate data); typically for concentrate form unless otherwise specified.

Related product information:

♦ Refer to Section 16 for the full text of any Comprehensive GHS-based Classification statements coded above.

♦ Refer to Section 16 for the list of sources utilized in the assessment and the Key / legend to abbreviations and acronyms.

♦ No significant adverse health effects are expected by any route for the miscellaneous hydrogen peroxide [H2O2, CAS# 7722- 84-1,-≤ 0.1% v/v in R8], salts, sugars, buffers, water, animal sera, and other chemicals found in the HRP conjugate, buffers with protein stabilizers, dyes, and sodium acetate solution, in the kit volumes and/or concentrations present [chemical or dilution is not subject to GHS,USHCS, ECCLP or other GHS-based hazard labeling].

♦ Component R1 contains < 0.1% of Cobalt (II) Chloride [CAS# 7646-79-9, EC No. 231-589-4], which is classified as an IARC Group 2B (possible human carcinogen) and EU Category 2 carcinogen, and silica quartz [CAS# 14808-60-7, EC No. 238-87-4], which in dust form is classified as an ACGIH Class A2 (suspected human carcinogen) and IARC Group 1 (carcinogenic to humans). These materials are pelletized and sealed in a desiccant packet within the plate pouch, which is unlikely to generate significant dust under normal conditions of use and is thus not typically considered a health hazard.

However, health hazards could result from dusts generated if the packet is cut, split or otherwise compromised and a significant number of pellets were crushed to a powder form. Keep the desiccant packet intact as received in the microwell plate component package.

♦ According to the concept of Universal Precautions (29 CFR 1910.1030), all human blood and certain human body fluids must be treated as if known to be infectious for HIV, HBV and other bloodborne pathogens. No known test method can offer complete assurance that products derived from human blood will not transmit infection; thus, they should be handled as though they contain infectious agents. Furthermore, individual patient samples being tested represent a heightened, unknown hazard. Aerosolization/inhalation, contact and mucous membrane exposure should be avoided during sample and kit handling.

Consider equipment that potentially comes in contact with human source material as contaminated until appropriately decontaminated.

♦ Do not eat, drink or smoke when using this product.

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GS HIV-1/HIV-2 PLUS O EIA

[Catalog # 25256]

♦ Wear protective gloves / protective clothing / eye protection / face protection. Take off contaminated clothing and wash before reuse.

SECTION 4: EMERGENCY FIRST AID MEASURES

Health Effects: Symptoms of over exposure may include headache and dizziness, congestion. Skin contact may result in dermatitis and may cause allergic skin reaction upon repeated exposure. May be toxic to developing fetus, generally at concentrations and volumes that greatly exceed that of this kit.

Eye Contact: Flush eyes with copious water for at least 15 minutes. Ensure adequate flushing by separating the eyelids with fingers while flushing with water. OBTAIN MEDICAL ATTENTION.

Skin Contact: Remove contaminated clothing. Flush skin with copious water and wash affected area with soap and water. If blood-to-blood contact occurs, or if more severe symptoms develop, consult a physician.

Inhalation: Remove person from exposure area to fresh air. Generally, this aqueous product is not a significant inhalation hazard in the kit volumes and concentrations present. If breathing becomes difficult, immediately call for emergency medical assistance. Treat symptomatically and supportively.

If Swallowed: If ingested, rinse out mouth thoroughly with water, provided the person is conscious, and OBTAIN MEDICAL ATTENTION. Call a physician or the local poison control center. Treat symptomatically and supportively. If vomiting occurs, keep head lower than hips to prevent aspiration.

Notes to

Physician According to the OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030), Universal Precautions apply.

Persons handling human blood source samples should be offered hepatitis B vaccination prior to working with human source material.

SECTION 5: FIREFIGHTING MEASURES Extinguishing Media: Use extinguishing media appropriate for the surrounding fire.

Hazardous Combustion Products: May emit toxic oxides of carbon and nitrogen under fire conditions.

Special Firefighting Procedures: Conventional firefighting full protective equipment (with NIOSH-approved self-contained breathing apparatus) and procedures appropriate for the surrounding fire should be sufficient.

SECTION 6: ACCIDENTAL RELEASE MEASURES

♦ Avoid direct contact with skin, eyes, mucous membranes and clothing by wearing appropriate lab Personal Protective Equipment (PPE), including gloves, lab coat and eye/face protection.

♦ In the event of a hazardous material spill, contain the spill if it is safe to do so and immediately move to a safe area, free from potential aerosols, to decontaminate and/or safely remove any contaminated clothing, as necessary. IF ON SKIN (or hair):

Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower. Isolate the hazard area and ventilate if appropriate. Ensure that appropriate spill cleanup materials and PPE are available and used.

♦ Prevent material from entering sewers, waterways or confined spaces.

♦ Follow established laboratory policy and applicable CDC/NIH biosafety and/or OSHA/WISHA hazardous material spill and/or NFPA/Fire Code guidelines for appropriate hazardous chemical and/or biological material spill response and cleanup.

Avoid release to the environment.

♦ Wear appropriate PPE. Immediately, and on-site if possible: Decontaminate Biohazard/Human Source Material spills, which should always be treated as potentially infectious, including the area, spill materials and any contaminated surfaces or equipment. Utilize an appropriate chemical decon agent or disinfectant that is effective for the known or potential pathogens relative to the samples involved (commonly a 1:10 dilution of bleach, 70-80% Ethanol or Isopropanol, an iodophor (such as Wescodyne Plus), or a phenolic, etc.).

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GS HIV-1/HIV-2 PLUS O EIA

[Catalog # 25256]

♦ Clean the spill area with water and wipe dry. Spills can also be absorbed with an appropriate inert material (e.g. spill pillows, absorbent pads, etc.), which are secured in an appropriate, labeled, sealed container. Material used to absorb the spill may require hazardous material waste disposal. Infectious, Chemical and Laboratory wastes must be handled and discarded in accordance with all local, regional, national and international regulations.

♦ Refer to Sections 8 and 13 for more specifics.

SECTION 7: HANDLING AND STORAGE INFORMATION

Handling: This test kit should be handled only by qualified personnel trained in laboratory procedures and familiar with their potential hazards. Follow proper Good Laboratory Practices and safety guidelines for handling chemical, biological and laboratory hazards.

Do not smoke, eat, or drink in areas where patient samples and kit reagents are handled. Wash your hands after use.

Wear appropriate personal protective equipment (PPE) including gloves, lab coat or equivalent and eye/face protection.

Keep containers tightly closed; avoid splashing, spills and the generation of aerosols.

Handle all human source materials, specimens and equipment used to perform the operations as though they were capable of transmitting infectious disease, as per Standard and Universal Precautions.

All personal protective equipment should be removed before leaving the work area. Refer to Section 8 for more specifics.

Avoid release to the environment. Do not allow undiluted product hazardous chemical ingredient or large quantities of it to reach ground water or water course.

Consult with your Environmental Health & Safety Office for assistance..

Storage: Store according to product and label instructions (generally at 2-8 °C).

Caution, consult accompanying documents. Read and follow all the precautions and warnings in the kit product instructions for use. Refer to the Instructions For Use / Package Insert for additional product information.

For in vitro diagnostic use.

SECTION 8: EXPOSURE CONTROL / PERSONAL PROTECTION MEASURES

Control Parameters – Component chemicals with limit values that require monitoring at the workplace: The product does not contain any relevant quantities of materials with critical values that have to be monitored at the workplace.

Chemical CAS-No. Value Control parameter Update Basis Hydrochloric

acid

7647-01-0 TLV – C 2 ppm 2007-01-01 USA. ACGIH Threshold Limit Values (TLV) PEL – C 7 mg/m³ *

5 ppm

2006-02-28 USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants REL – C

IDLH

7 mg/m³ 5 ppm 50 ppm

2005-149 [SEP-2007]

USA. National Institute for Occupational Safety and Health (NIOSH)

* The value in mg/m³ is approximate. Ceiling limit is to be determined from breathing-zone air samples.

Remarks: TLV CARCINOGENICITY DESIGNATION A4 – Not Classifiable as a Human Carcinogen: Inadequate data on which to classify the substance as a human and/or animal carcinogen.

Hydrogen

peroxide 7722-84-1 TWA – TLV 1 ppm 2007-01-01 USA. ACGIH Threshold Limit Values (TLV) TWA – PEL 1.4 mg/m³ *

1 ppm 1997-08-04 USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants REL

IDLH

1.4 mg/m³ 1 ppm 75 ppm

2005-149 [SEP-2007]

USA. National Institute for Occupational Safety and Health (NIOSH)

* The value in mg/m³ is approximate

Remarks: TLV CARCINOGENICITY DESIGNATION A3 – Animal Carcinogen: Substance is carcinogenic in laboratory animals under conditions that are not considered relevant to worker exposure. Available human studies and evidence suggest that the substance is not likely to cause cancer in humans except under unusual or unlikely routes or levels of exposure.

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GS HIV-1/HIV-2 PLUS O EIA

[Catalog # 25256]

Chemical CAS-No. Value Control parameter Update Basis

Worker exposure to an A3 carcinogen should be controlled to levels as low as reasonably achievable below the TLV.

Dimethyl

sulfoxide 67-68-5 TWA-WEEL 250 ppm 2014 USA: Workplace Environmental Exposure Levels

MAK 50 ppm (160

mg/m³)

2011 GERMANY:

Source: RTECS September 2013 Update and Raw Material Vendor Safety Data Sheet Additional information: The lists that were valid during the creation were used as basis.

The following personal protective equipment (PPE) is recommended to prevent blood or other potentially infectious or hazardous materials from reaching the user's work or street clothes, skin, mouth, mucous membranes and eyes, or hazard inhalation, under normal conditions of use and for the time during which the protective equipment is utilized:

Ventilation: Adequate lab ventilation is required. It is recommended that users handle potentially infectious human source material / patient samples in a biological safety cabinet (BSC), expressly if aerosols might be generated.

Eye / Face Protection:

Wear ANSI approved safety glasses, goggles or face shield with safety glasses or goggles. Contact lenses should not be worn when handling lab hazards.

Protective Gloves:

Suitable gloves must be worn at all times when handling kit reagents or patient samples to provide skin protection from splash and intermittent contact. Synthetic gloves, such as Nitrile, Neoprene and Vinyl, are recommended because they are sturdy, effective and contain no natural latex ingredients associated with latex glove allergic reactions. Disposable (single use) gloves should be changed often and never be reused. Wash hands thoroughly after removing gloves.

Protective Clothing:

Wear a lab coat, clinic jacket, gown, apron and/or smock. Disposable clothing is strongly recommended when handling biohazardous material. If reusable clothing is used, procedures for handling potentially infectious laundry under the OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030) are required.

Respiratory

Protection: Do not breathe mist / vapors/vapours / spray.

Other: All personal protective equipment should be removed before leaving the work area and placed in an appropriately designated area or container for storage, processing, decontamination or disposal. Protective coverings such as plastic wrap, aluminum foil, or imperviously-backed absorbent pads used to cover equipment and/or surfaces must be removed and replaced if they become overtly contaminated.

SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES

Appearance: Variable, generally aqueous liquids. Exceptions are the solid microtiter plate and related materials.

Odour/odor: No applicable information was found. Odour/odor threshold: Not Established.

pH: Most of the liquid chemical components are between pH 6 and 8, Exceptions are the following acidic solutions: Buffer at pH ~4, and Chromogen at pH ~1.5.

Boiling point: Undetermined. Melting point: Undetermined.

Flash point: Not Applicable.

Flammable limits: LEL/LFL is Not Applicable; UEL/UFL is Not Applicable Evaporation rate: No applicable information was found.

Fire hazard: Although the components have not been tested for fire hazard and explosion data, being water-based, they are not expected to be fire hazards, but some of the kit packaging materials may burn under fire conditions.

Vapor/vapour pressure: No applicable information was found.

Vapor/vapour density: No applicable information was found.

Relative density: Variable, approximately 1.

Solubility: The liquid chemical components are soluble in water.

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GS HIV-1/HIV-2 PLUS O EIA

[Catalog # 25256]

Partition coefficient

(n-octanol/water): No applicable information was found.

Auto igniting: Product is not known to be self-igniting.

Decomposition temperature:

No applicable information was found.

Viscosity: No applicable information was found.

Danger of explosion: Product is not known to present an explosion hazard.

No other standard characteristics applicable to the identification or hazards of the product are known.

SECTION 10: STABILITY AND REACTIVITY INFORMATION

NOTE: Chemical reactions that could result in a hazardous situation (e.g. generation of flammable or toxic chemicals, fire or detonation) are listed here. Although not intended to be complete, an overview of important reactions involving common chemicals is provided to assist in the development of safe work practices.

Chemical Stability / Reactivity: Components are stable with no known inherent significant reactivity, except the acidic solutions, which may have an exothermic reaction with certain chemicals, particularly strong bases and reducing agents.

Conditions and/or Materials to Avoid: None known when used as intended.

Hazardous Decomposition Products: May emit toxic oxides of carbon and nitrogen under fire conditions.

Hazardous Polymerization: Has not been reported to occur.

SECTION 11: TOXICOLOGICAL INFORMATION -- GENERAL COMPOSITE

Refer to Sections 2 and 3 for the kit component concentrations. The composite toxicological information for this product is:

Acute Health Effects

Acute Toxicity: May be detrimental in contact with skin, if swallowed, and to eyes upon contact; in case of contact with eyes, immediately rinse with copious water and seek medical attention.

Primary Irritant Effect: May slightly irritate eyes or skin, depending on amount and contact time.

Skin Corrosivity / Metal

Corrosion: The EIA Chromogen (11X) solution in this product has been evaluated with the CORROSITEX^® test method to determine its corrosive potential. The results of this testing classified this solution as non-corrosive.

Serious Eye Damage / Irritation: May slightly irritate eyes or skin, depending on amount and contact time.

STOT-Single Exposure: No applicable information was found.

Aspiration Hazard: No applicable information was found.

Other Acute Health Effects: No significant other acute health effect known.

Biohazard Potential:

The human sera (plasma) in the components were tested and found non-reactive for HBsAg and antibodies to HCV (and antibodies to HIV for the Negative and Group O Positive Controls). The C1 and C2 Positive Controls were heat-treated to inactivate the HIV. Human sera in reagents were tested and found non-reactive for Hepatitis B surface antigen and antibodies to HCV (the Negative control is also non-reactive for antibodies to HIV). No known test method can offer complete assurance that HIV, hepatitis B or C virus or other infectious agents are absent. Moreover, patient blood samples tested with this kit represent an unknown, heightened hazard. Employ Standard and Universal Precautions; handle these reagents, all human blood and specimens as if capable of transmitting infectious disease, in a Biosafety Level 2 laboratory, applying the guidelines from the current CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, WHO Laboratory Biosafety Manual or equivalent. Persons handling blood samples should have the option of receiving hepatitis B vaccination.