RPR Carbon Antigen test, All sizes

Hazard statements

Components contain less than 0.1% wt of Sodium Azide (NaN3) as preservative. The control component(s) in each of the above products contain(s) materials derived from human or animal sources. The source material used to prepare these controls are tested by an approved method for the presence of human immunodeficiency virus (HIV) as well as for Hepatitis B surface antigen; and only those materials found to be negative (not repeatedly reactive) are used to prepare products for sale. PMX8.00.18.x.xxxx D.13 Issued for Prepared by. Reviewed by. Approved by. Page QA R&D QA 2 of 6 File Title: Document Title: Date Issued Atlas Medical Product File. 03.11.2019 Item Title: Item Code: Issue Level: RPR Carbon Antigen. 8.00.18.x.xxxx 1.3 When used in accordance with the Principles of Good Laboratory Practice, Good Standards of Occupational Hygiene and the instructions stated in the product insert, these products are not considered to present a hazard to health. Information concerning particular hazards for human and environment: Under the recommended conditions of use, there is no risk of exposure to any of the materials contained in the test.

Health hazards

Data Sodium Azide: Spill: Not applicable. Exposure Controls: Not applicable. Personal Protection: Not applicable. Physical Properties: Not applicable. Stability/Reactivity: Stable. Non-reactive in this test. Poison, Do Not Inhale or Swallow. First Aid Measures: Inhale: Remove to fresh air. Contact: Flush with water for 15 minutes. Swallow: If conscious, wash mouth out with water. Call Physician. 8. Handling and Storage. Information for safe handling: − The reagents in this kit contain sodium azide as a preservative. Sodium azide has been reported to form lead or copper azide in laboratory plumbing which may explode on percussion. Flush drains with water thoroughly after disposing of fluids containing sodium azide. PMX8.00.18.x.xxxx D.13 Issued for Prepared by. Reviewed by. Approved by. Page QA R&D QA 3 of 6 File Title: Document Title: Date Issued Atlas Medical Product File. 03.11.2019 Item Title: Item Code: Issue Level: RPR Carbon Antigen. 8.00.18.x.xxxx 1.3 − It should be noted, however, that there is no guarantee for products derived from human and animal sources not to transmit infectious diseases and thus should be handled with care. − Keep out of reach of children.

TOXICOLOGICAL INFORMATION

Exposure above acceptable limits may be harmful 6. Fire & Explosion Hazard Data. Non-flammable. Using the reagents according to protocol should not incur a fire or explosion hazard. In case of fire, use water, foam, carbon dioxide, or dry chemical, as suitable for the surrounding fire and materials. 7. Accidental release measures. Acute toxicity: Quantitative data on the toxic effects of this product is not available. Primary effects: After skin contact: No irritating effects known. After eye contact: No irritating effects known. Sensitization: No sensitizing effects known. 13. Ecological information.

Storage

Store in the original container at 2-8°C. Requirements to be met by storerooms and receptacles: − No special requirements. 9. Exposure control and personal gear. Ingredients with limit values that require monitoring in the workplace: The product does not contain any relevant quantities of materials with critical values that have to be monitored in the workplace. Personal protective equipment: General protective and hygienic measures: Adhere to good laboratory practices (GLP). Wash hands before breaks and at the end of work. Respiratory protection: Not required. Protection of hands: Disposable gloves (for sample handling). Material of gloves: Latex/natural rubber. Penetration time of glove material: Glove resistance is not critical as the gloves are intended to provide protection against the sample material. Eye protection: Safety glasses are recommended. Body protection: Lab coat. 10. Physical and chemical properties. General Information Besides other antibodies, Treponema Pallidium produces non-Treponemal antibodies (reagin) in syphilitic persons. These antibodies can be detected by RPR antigen. ATLAS RPR card test is a macroscopic screening test for the qualitative and quantitative detection of reagin antibodies in serum or plasma. The kit contains RPR antigen which is based on the easy to use VDRL carbon antigens. In the presence of the reagin, the antigen causes flocculation of the carbon particles, which appears as black clumps. The charcoal particles contained in the antigen suspension enhances the visual appearance of the coagglutination in positive samples Colour: Carbon RPR Antigen and Straw controls. Odor: Odorless. Flash point: Not applicable. Self-igniting: Product is not self-igniting. Danger of explosion: Product does not present an explosion hazard. PMX8.00.18.x.xxxx D.13 Issued for Prepared by. Reviewed by. Approved by. Page QA R&D QA 4 of 6 File Title: Document Title: Date Issued Atlas Medical Product File. 03.11.2019 Item Title: Item Code: Issue Level: RPR Carbon Antigen. 8.00.18.x.xxxx 1.3 11. Stability and Reactivity Data. Stability: The product is stable in accordance with the recommended storage conditions. Materials to be avoided: None. Hazardous reactions: No dangerous reactions known. Hazardous decomposition products: No dangerous decomposition products known.