General Information
Product name
LumiraDx INR Quality Controls Level 1 and 2
CAS No.
9045-22-1
REACH No
is
1.2.1 Relevant identified uses
In-vitro laboratory reagent or component, liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx INR Test Strip
Icons in SDS
Company Information
company name
LumiraDx UK Ltd
e-mail address of the competent person responsible for the Safety Data Sheet
customerservices@lumiradx.com
Section 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 INR Quality Control Kit 2 of 19
2.3 Other hazards
Biohazard The plasma control contains human source material that was tested and found nonreactive for HIV antibody, Hepatitis B Surface Antigen and Anti-HCV 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.
