i-STAT PTplus Control Level 1 (Plasma); i-STAT PTplus Control Level 2 (Plasma)

SECTION 2: Hazards identification

According to Regulation (EC) No. 1272/2008 (CLP) Classification of the substance or mixture

Adverse physicochemical, human health and environmental effects

No additional information available

2.3 Other hazards

The mixture does not contain substance(s) included in the list established in accordance with Article 59(1) of REACH for having endocrine disrupting properties, or is not identified as having endocrine disrupting properties in accordance with the criteria set out in Commission Delegated Regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at a concentration equal to or greater than 0,1 % This product contains human-sourced components. No known test method can offer complete assurance that products derived from human sources will not transmit infection. Therefore, all human-sourced materials should be considered potentially infectious. The human-sourced material used in this product has been tested and found to be: - Nonreactive for HBsAg (hepatitis B surface antigen) - Nonreactive for HCV (hepatitis C virus) - Nonreactive for HIV-1 Ag or HIV-1 RNA (human immunodeficiency virus type 1 antigen or human immunodeficiency virus type 1 ribonucleic acid)

2.1 Classification of the substance or mixture

Classification according to Regulation (EC) No. 1272/2008 [CLP] and US Hazcom 2012 This product has been evaluated per the classification criteria in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). This product does not meet the criteria for classification in accordance with the GHS. Adverse physicochemical, human health and environmental effects No additional information available