BioPlex 2200 HIV Ag-Ab Control Set (RxOnly)

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. The GHS, US HCS, EC CLP and related classifications were made according to the latest editions and expanded upon from company and literature data. Refer to Section 16 for the full text of any solely abbreviated or coded hazard statements provided below. Refer to Section 16 for the key / legend to abbreviations and acronyms. SDSen663-3435 Revision E (February 2020) 1 of 16 Component

Contains

The negative controls are provided in a human serum matrix made from defibrinated plasma. Normal human HIV Ag-Ab serum/plasma that is non-reactive for HBsAg and antibodies to HIV and HCV. Negative Control - 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; BioPlex 2200 P501. 3 x 1.5 mL - 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  0.1% sodium benzoate [C7H5O2Na], CAS# 532-32-1, EC No 208-534-8. Not subject to GHS, WARNING US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with < 0.1% sodium azide [NaN3], CAS# 26628-22-8 and EC No 247-852-1. 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. - Purified HIV-1 antigen (from viral lysate inactivated with a chaotropic agent) in Tris Buffer [CAS# 77-86-1] with HIV-1 Antigen protein stabilizer (bovine, CAS# 9048-46-8) (pH 7.3). Positive Control - < 1% Sodium chloride [NaCl], CAS# 7647-14-5, EC No 231-598-3. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. BioPlex 2200 HIV Ag-Ab - Preserved with  0.3% ProClin 300 ( 0.009% active ingredient), EC Index No 613-167-00-5 with CAS# 55965-84-9 [GHS / 2008/1272/EC Classification: WARNING; GHS07; H317, H412; P273, P280; P302 + P352, P333 + P313; 3 x 1.5 mL P501.] - Preserved with  0.1% sodium benzoate [C7H5O2Na], CAS# 532-32-1, EC No 208-534-8. Not subject to 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 GHS, US HCS, WARNING EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Heat-treated Human serum/plasma containing HIV-1 and HIV-2 immunoglobulin, non-reactive for HBsAg and HIV-1/HIV-2 antibody to HCV. Antibody - Rabbit serum containing HIV-1 Group O antibody diluted in normal human serum; negative for HIV and HCV Positive antibodies and HBsAg. Control BioPlex 2200 - 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; HIV Ag-Ab P501. 3 x 1.5 mL - 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  0.1% sodium benzoate [C7H5O2Na], CAS# 532-32-1, EC No 208-534-8. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. WARNING - Preserved with < 0.1% sodium azide [NaN3], CAS# 26628-22-8 and EC No 247-852-1. 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. Markings according to the United Nations (UN) Globally Harmonized System (GHS), United States Hazard Communication Standard (US HCS), European Commission (EU) 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): SDSen663-3435 Revision E (February 2020) 2 of 16 0.3% ProClin 300 [ 0.009% 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 Statements: 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

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