LumiraDx D-Dimer Quality Control Level 1 and 2

2.1 Classification of the substance or mixture

Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.

2.2 Label elements

Not a hazardous substance or mixture according to Regulation (EC) No.1272/2008. The product does not need to be labelled in accordance with the Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals. Document Name: Safety Data Sheet LumiraDx D-Dimer Quality Control Kit 2 of 10

2.3 Other hazards

Biohazard The product contains material of human origin. This material has been tested for the HIV (Human Immunodeficiency Virus) Antibody, HBs Ag and HCV and found to be non-reactive at the donor stage. This product, as with all human based specimens, should be treated as potentially infectious and handled with proper laboratory safety procedures to minimize the risk of transmission of infectious disease. This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher. This control contains sodium azide (<0.1%). Avoid ingestion or contact with skin or mucous membranes. Sodium azide reacts with lead or copper plumbing to form potentially explosive azides. When disposing of such reagents flush with large volumes of water to prevent azide build up. Exposed metal surfaces should be cleaned with 10% sodium hydroxide.