GS HIV Combo Ag/Ab EIA

Hazard statements (CLP)

H290, H314, H317, H412

Code

Statements

H290

May be corrosive to metals

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 *

Contains

R1. Microwell Strip - Microwell plate coated with monoclonal antibodies to HIV p24 (mouse) and HIV-1 and HIV-2 antigens. Plate (2 plates) - Potential residue of ProClin 300 used as a production preservative (aspirated prior to drying strips). - Tabs are labeled “JJ” - Contains sealed pelletized desiccant packet: 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. R2. Wash Solution - Sodium chloride (NaCl) [CAS# 7647-14-5, EC No 231-598-3] aqueous solution with < 2% Tween 20 Concentrate (30X) (C58H114O26) [CAS# 9005-64-5, EC No 585-580-06-X] (clear liquid). Not subject to GHS, US HCS, EC CLP 1 bottle (120 mL) and analogous global GHS-based regulatory requirements in this product mixture and concentration. Catalog No. 25261 C0. Negative Control - Normal human serum/plasma that is non-reactive for HBsAg, HIV-1 Ag and antibodies to HIV and HCV (amber 1 vial (1.5 mL) / yellow liquid). Catalog No. 26220 - Preserved with 0.16% ProClin 950 containing 0.016% active ingredient: 9.5-9.9% 2-methyl-4-isothiazolin-3- one (C4H5NOS); CAS# 2682-20-4, EC No 220-239-6. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. C1. HIV-1 Ab Positive - Heat-treated human serum/plasma containing HIV-1 antibody, non-reactive for HBsAg and antibody to HCV Control (yellow or green aqueous solution). 1 vial (1.5 mL) - Preserved with 0.16% ProClin 950 containing 0.016% active ingredient: 9.5-9.9% 2-methyl-4-isothiazolin-3- Catalog No. 26221 one (C4H5NOS); CAS# 2682-20-4, EC No 220-239-6. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. C2. HIV-2/O Ab - Murine monoclonal antibody to HIV-2 and rabbit antibody to HIV-1 Group O diluted in normal human Positive Control serum/plasma; non-reactive for HBsAg and antibodies to HCV (yellow or green aqueous solution). 1 vial (1.5 mL) - Preserved with 0.16% ProClin 950 containing 0.016% active ingredient: 9.5-9.9% 2-methyl-4-isothiazolin-3- Catalog No. 26222 one (C4H5NOS); CAS# 2682-20-4, EC No 220-239-6. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. C3. HIV Ag Positive - Purified HIV-1 viral lysate antigen inactivated with heat and a chaotropic agent, in synthetic diluent (bovine) Control (blue-green aqueous liquid). 1 vial (1.5 mL) - Preserved with 0.5% ProClin 300 (0.015% active ingredient), EC Index No 613-167-00-5 with CAS# 55965-84- 9. GHS \ US HCS \ EC CLP Classification: WARNING; GHS07; H317, H412; P273, P280; P302 + P352, Catalog No. 26223 P333 + P313; P501. 0.1% Tartrazine [FD&C Yellow #5, Acid Yellow 23; C16H9N4O9S23Na]; CAS# 1934-21-0; EC 217-699-5. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. WARNING - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. C4. Cutoff Calibrator - Normal human serum/plasma that is non-reactive for HBsAg, HIV-1 Ag and antibodies to HIV and HCV (amber 3 vials (1.7 mL) / yellow liquid). Catalog No. 26224 - Preserved with 0.16% ProClin 950 containing 0.016% active ingredient: 9.5-9.9% 2-methyl-4-isothiazolin-3- one (C4H5NOS); CAS# 2682-20-4, EC No 220-239-6. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. Component * R6. Conjugate 1 - Biotinylated polyclonal antibodies (sheep) to HIV p24 Ag in a buffer with protein stabilizers (bovine and ovine) 1 bottle (10 mL) and yellow-green dye. Catalog No. 26225 - Preserved with 0.5% ProClin 300 (0.015% active ingredient), EC Index No 613-167-00-5 with CAS# 55965-84- 9. GHS \ US HCS \ EC CLP Classification: WARNING; GHS07; H317, H412; P273, P280; P302 + P352, P333 + P313; P501. - Diluted < 0.1% Bromocresol Purple [C21H16Br2O5S], CAS# 115-40-2, EC No 204-087-8. Not subject to GHS, WARNING US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. R7a. Conjugate 2 - Peroxidase-labeled Streptavidin and peroxidase-labeled HIV-1 and HIV-2 antigens in a buffer with protein Concentrate (11X) stabilizers (bovine and caprine) and green dye. 1 vial (12 mL) - Preserved with 0.5% ProClin 300 (0.015% active ingredient), EC Index No 613-167-00-5 with CAS# 55965-84- 9. GHS \ US HCS \ EC CLP Classification: WARNING; GHS07; H317, H412; P273, P280; P302 + P352, P333 + P313; P501. - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. WARNING R7b. Conjugate 2 - Buffer (pH neutral) with protein stabilizers (bovine and ovine) and red dye (red aqueous liquid). Diluent, - Preserved with 0.5% ProClin 300 (0.015% active ingredient), EC Index No 613-167-00-5 with CAS# 55965-84- 1 bottle (120 mL) 9. GHS \ US HCS \ EC CLP Classification: WARNING; GHS07; H317, H412; P273, P280; P302 + P352, P333 + P313; P501. - Diluted 0.1% Amaranth [FD&C Red #2; C20H11N2O10S33Na], CAS# 915-67-3, EC No 213-022-2. [IARC Group 3]. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. WARNING - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. R8. Substrate Buffer, - Dilute citric acid (C6H8O7, CAS# 79-92-9, EC No 201-069-1) / sodium acetate buffer, (pH ~ 4.0, clear liquid). 1 bottle (120 mL) - < 5% dimethylsulfoxide [DMSO - C2H6OS], CAS# 67-68-5, EC No 200-644-3. Catalog No. 26181 - < 0.1% hydrogen peroxide [H2O2], CAS# 7722-84-1, EC No 231-765-0. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. R9. Chromogen (11X) - ≤ 0.25% 3,3’,5,5’ tetramethylbenzidine dihydrochloride [TMB– C16H20N22HCl], CAS# 207738-08-7, 1 bottle (12 mL) EC No 264-769-6. Catalog No. 26182 - ≤ 0.04 N hydrochloric acid [~ 0.3% HCl, CAS# 7647-01-0, EC No 231-595-7] solution (pH ~ 1.5, clear liquid). Not subject to US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. R10. Stopping Solution - 1N H2SO4 (4.4% w/w Sulfuric acid), CAS# 7664-93-9, EC No 231-639-5 [pH  2, clear liquid]. Severely 1 bottle (120 mL) irritating to skin, corrosive to eyes. GHS \ US HCS \ EC CLP: DANGER! GHS05; H290, H314; P280; Catalog No. 25260 P301 + P330 + P331, P305 + P351 + P338; P501. DANGER! * Replacement, optional and separately purchased component Catalog numbers are provided in this column where available. Markings according to the United Nations (UN) Globally Harmonized System (GHS), United States Hazard Communication Standard (US HCS), European Commission (EC) 2008/1272/EC (EC CLP) guidelines and analogous GHS-based global regulations: This product has been conservatively classified and labeled in accordance with United Nations (UN) GHS, United States Hazard Communication Standard (US HCS), related European Commission (EC) 2008/1272/EC (EC CLP) guidelines and applicable analogous GHS-based global regulations. The following regulated hazardous chemical concentrations are found in product component(s): Component R10 - 1N H2SO O4 [4.4% w/w Sulfuric acid], CAS# 7664-93- -9, EC No 231- 639-5 (pH  2); ; severely irrita ating to skin, corrosive to eyes. [This STOP solution has been evalu uated with the CORROSITEX test method to determine its corrosive e potential and c classification. Th he results of this is testing classif fied this STOP s solution as Class s: 8, Packing group II ( (UN2796)] Comprehen nsive GHS Base ed Classification n: Skin Co orrosive Catego ory 1B Serious s eye damage (C Category 1) Label(s): Signal Wo ord: DANGER! Label Haz zard Statements: H290 May be corros ive to metals. H314 Causes severe skin burns and d eye damage.

Precautionary statements

statements for p product intende d use and as cod dified on the pro oduct label) P280 Wear protective e gloves / protec ctive clothing / ey ye protection / f face protection. P301 + P330 + P331 IF SWALLOW WED: Rinse mout th. Do NOT indu uce vomiting. P303 + P361 + P353 IF ON SKIN (o or hair): Remove e/Take off immed diately all conta aminated clothing g. Rinse skin wi ith water/shower. P305 + P351 + P338 IF IN EYES: R Rinse cautiously w with water for se everal minutes. R Remove contact t lenses, if presen nt and easy to do. Continue rin nsing. P501 This material an nd its container m must be disposed d of as hazardou us waste. Suppleme ental Precautiona ary Statements (a (additional preca autions to consid der relative to sp pecific customer use): P308 + P313 If exposed or co oncerned: Get m medical advice/ a attention. P405 Store locked up p. Source Raw Material v vendor SDS, CC COHS databases and regulatory research] Component C3, R6, R7a a and R7b - 0.5% % ProClin 300 [ 0.015%. act tive ingredients – reaction ma ass of: 5-chloro -2-methyl-4- isothiazol lin-3-one (C4H H4ClNOS; CAS S# 26172-55-4, EC No 247-500 0-7) and 2-m methyl-2H -isot thiazol-3-one (C4H5NO OS; CAS# 2682-2 20-4, EC No 220 0-239-6) (3:1)], EC Index No 61 13-167-00-5 with h CAS# 55965-8 84-9. Comprehen nsive GHS Base ed Classification n: Skin Se ensitizer Catego ory 1 Label(s): Signal Wo ord: WARNING Label Haz zard Statements: H317 May caus se an allergic sk kin reaction. H412 Harmful to aquatic life w with long lastin ng effects. Precaution nary Statements (statements for p product intende d use and as cod dified on the pro oduct label): P273 Avoid release to o the environme ent. P280 Wear protective e gloves / protec ctive clothing / ey ye protection / f face protection. P302 + P352 IF ON SKIN: W Wash with plenty y of soap and wa ater. P333 + P313 If skin irritation n or rash occurs: Get medical adv vice/ attention. P501 Dispose of cont tents and contain ner in accordanc ce to local, region nal, national and d international re egulations. Suppleme ental Precautiona ary Statements (a (additional preca autions to consid der relative to sp pecific customer use): P261 Avoid breathing g mist / vapors/v vapours / spray. P272 Contaminated w work clothing sh hould not be allow wed out of the w workplace. Source Raw Material v vendor SDS, CC COHS databases and regulatory research]