BioPlex 2200 System 25-OH Vitamin D Reagent Pack

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

Bead Set - Dyed beads coated with anti-25-OH Vitamin D, an Internal Standard bead (ISB), a Serum Verification bead BioPlex 2200 (SVB) in phosphate buffer with protein stabilizers (bovine, CAS# 9048-46-8) (pH 7.4). 25-OH Vitamin D - 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 10 mL vial analogous global GHS-based regulatory requirements in this product mixture and concentration. (Faint brown liquid) - < 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 < 1% ProClin 950 containing < 0.1% 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 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. Release Buffer - 25-OH Vitamin D releasing reagents in citrate and trisodium citrate acid buffer at pH 4.1. BioPlex 2200 - 50-100% water [H20] CAS# 7732-18-5, EC No 231-791-2. Not subject to UN GHS, US HCS, EC CLP and 25-OH Vitamin D analogous global GHS-based regulatory requirements in this product mixture and concentration. 1 x 10 mL vial - < 3% Citric acid, Anhydrous [C6H8O7], CAS# 77-92-9, EC No 201-063-1. Not subject to UN GHS, US HCS, (Clear liquid) EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - < 3% Trisodium Citric acid, Dihydrate [Na3C6H5O72H2O], CAS# 6132-04-3, EC No 200-675-3. 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. - Preserved with < 1% ProClin 950 containing < 0.1% 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 UN GHS, HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. Conjugate 1 - Biotinylated 25-OH Vitamin D conjugate and biotinylated anti-human FXIII antibody conjugate (murine) in BioPlex 2200 phosphate buffer with protein stabilizers (bovine CAS# 9048-46-8) and chemical blockers (pH 7.4). 25-OH Vitamin D - 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 vial analogous global GHS-based regulatory requirements in this product mixture and concentration. (Clear liquid) - < 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 < 1% ProClin 950 containing < 0.1% 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 UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with < 0.1% Bronidox (m-Dioxane, 5-Bromo-5-nitro-1,3-) [C4H6BrNO4], CAS#: 30007-47-7, EC No: 250-001-7. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory labeling and related requirements. SDSen665-3750 Revision C (February 2020) 2 of 16 Component Conjugate 2 - Phycoerythrin conjugated streptavidin (SA-PE) in a buffer comprising protein stabilizer (bovine CAS# 9048-46- BioPlex 2200 8), chemical blockers and detergent (Tween 20) (pH 6.1). 25-OH Vitamin D - 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 vial analogous global GHS-based regulatory requirements in this product mixture and concentration. (Pink aqueous liquid) - < 1% MES buffer (2[N-Morpholino] ethane-sulfonic acid – C6H13NO4S  H2O], CAS# 4432-31-9, EC No 224- 632-3. 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. - Preserved with < 1% ProClin 950 containing < 0.1% 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 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. 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: The chemical dilutions in this product are not subject to classification or labeling according 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.