BioPlex 2200 HIV Ag-Ab Reagent Pack

Hazard statements (CLP)

H317, H412

Code

Statements

H317

May cause an allergic skin reaction

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. SDSen665-3455 Revision D (February 2020) 1 of 15 Component

Contains

Bead Set - Reagent with dyed beads coated with monoclonal antibody against HIV-1 p24 antigen or purified HIV-1/ BioPlex 2200 HIV-2 antigen (recombinant protein or peptides), Internal Standard Beads (ISB), Serum Verification HIV Ag-Ab Beads (SVB), and Signal Normalization Beads (SNB), in buffer with protein stabilizers (bovine CAS# 1 x 5 mL 9048-46-8, murine and human IgG) (pH 7.4). (Faint brown - 50-100% water [H20] CAS# 7732-18-5, EC No 231-791-2. Not subject to UN GHS, US HCS, EC CLP and liquid) analogous global GHS-based regulatory requirements in this product mixture and concentration. -  1% Triethanolamine hydrochloride [C6H15NO3HCl] CAS 637-39-8, EC No 211-284-2. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - < 1% Sodium chloride [NaCl], CAS# 7647-14-5, EC No 231-598-3. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. WARNING - Preserved with  0.3% ProClin 300 ( 0.009% 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  0.1% sodium benzoate [C7H5O2Na], CAS# 532-32-1, EC No 208-534-8. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with < 0.1% sodium azide [NaN3], CAS# 26628-22-8 and EC No 247-852-1. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration.. Conjugate 1 - Reagent with biotinylated peptides of HIV-1 (M & O) and HIV-2, biotinylated polyclonal sheep antibodies to HIV 1 BioPlex 2200 p24 antigen, and biotinylated Factor XIII antibody with protein stabilizers (bovine, CAS# 9048-46-8, and human HIV Ag-Ab IgG) in a phosphate buffered saline solution (pH 7.4). 1 x 10 mL - 50-100% water [H20] CAS# 7732-18-5, EC No 231-791-2. Not subject to UN GHS, US HCS, EC CLP and (Yellow aqueous analogous global GHS-based regulatory requirements in this product mixture and concentration. - < 5% Glycerol [C3H8O3], CAS# 56-81-5, EC No 200-289-5. Not subject to UN GHS, US HCS, EC CLP and liquid) analogous global GHS-based regulatory requirements in this product mixture and concentration. - < 1% Sodium chloride [NaCl], CAS# 7647-14-5, EC No 231-598-3. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - 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, WARNING P333 + P313; P501. - Preserved with < 0.1% sodium azide [NaN3], CAS# 26628-22-8 and EC No 247-852-1. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. Conjugate 2 - Reagent with streptavidin conjugated to phycoerythrin with protein stabilizers (bovine CAS# 9048-46-8 and Human BioPlex 2200 IgG) in a phosphate buffered saline solution (pH 7.4). HIV Ag-Ab - 50-100% water [H20] CAS# 7732-18-5, EC No 231-791-2. Not subject to UN GHS, US HCS, EC CLP and 1 x 5 mL analogous global GHS-based regulatory requirements in this product mixture and concentration. (Pink aqueous - < 1% Sodium chloride [NaCl], CAS# 7647-14-5, EC No 231-598-3. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. liquid) - 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 < 0.1% sodium azide [NaN3], CAS# 26628-22-8 and EC No 247-852-1. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and WARNING concentration. Manual Reagent - No known hazardous chemical ingredients. Pack Piercer(1) - Sharp Biohazard. Markings according to the United Nations (UN) Globally Harmonized System (GHS), United States Hazard Communication Standard (US HCS) and 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 applicable United Nations (UN) GHS, United States Hazard Communication Standard (US HCS) and 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): SDSen665-3455 Revision D (February 2020) 2 of 15 0.5% ProClin 300 [ 0.015% active ingredients – reaction mass of 5-chloro-2-methyl-4-isothiazolin-3-one (C4H4ClNOS; CAS# 26172- 55-4, EC No 247-500-7) and 2-methyl-2H -isothiazol-3-one (C4H5NOS; CAS# 2682-20-4, EC No 220-239-6) (3 1)], EC Index No 613-167-00-5 with CAS# 55965-84-9. Comprehensive GHS Based Classification: Skin Sensitizer Category 1 Label(s):

Signal word

WARNING Label Hazard Statement: H317: May cause an allergic skin reaction. H412 Harmful to aquatic life with long lasting effects. Precautionary Statements (statements for product intended use and as codified on the product label): P273 Avoid release to the environment. P280 Wear protective gloves / protective clothing / eye protection / face protection. P302 + P352 IF ON SKIN: Wash with plenty of soap and water. P333 + P313 If skin irritation or rash occurs: Get medical advice/ attention. P501 Dispose of contents and container in accordance to local, regional, national and international regulations.

Supplemental label elements

Statements (additional precautions to consider relative to specific customer use) P261 Avoid breathing mist / vapours / spray. P272 Contaminated work clothing should not be allowed out of the workplace. [Source: Raw Material vendor SDS, CCOHS databases and regulatory research]