BioPlex 2200 Syphilis IgG Control Set

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 Component

Contains

Positive Control - The positive controls are provided in a human serum matrix made from defribrinated plasma with added known BioPlex 2200 IgG analyte concentrations of Treponema pallidum 15-kDa IgG, 17-kDa IgG and 47-kDa IgG derived from Syphilis IgG human disease state plasma. 4 x 1.5 mL - Each human donor unit used to manufacture this product was tested by FDA accepted methods and found non- reactive for Hepatitis B Surface Antigen (HBsAg), antibody to hepatitis C (HCV) and antibody to HIV-1/HIV-2. - 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; WARNING 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. Negative Control - The negative controls are provided in a human serum matrix made from defibrinated plasma. Normal human BioPlex 2200 serum/plasma that is non-reactive for HBsAg and antibodies to HIV and HCV. Syphilis IgG - Preserved with  0.3% ProClin 300 ( 0.009% active ingredient), EC Index No 613-167-00-5 with 2 x 1.5 mL 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 WARNING and concentration. 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 applicable 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): SDSen663-1430 Revision D (February 2020) 2 of 14  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): GHS07

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 / vapours / spray. P272 Contaminated work clothing should not be allowed out of the workplace. [Source: Raw Material vendor SDS, CCOHS databases and regulatory research] SDSen663-1430 Revision D (February 2020) 3 of 14