General Information
Revision date
2023-01-13
Product name
i-STAT PTplus Control Level 1 (Plasma); i-STAT PTplus Control Level 2 (Plasma)
1.2.1 Relevant identified uses
For In Vitro Diagnostic Use
Emergency telephone
(800) 424-9300, +1 (703) 527-3887
Icons in SDS
Company Information
company name
Abbott Point of Care Inc
e-mail address of the competent person responsible for the Safety Data Sheet
oustechsvc@apoc.abbott.com, techsvc@apoc.abbott.com
Section 2
SECTION 2: Hazards identification
Adverse physicochemical, human health and environmental effects
No additional information available 13/01/2023 (Version: A) EU-US SDS – EN (English) 1/10
2.2 Label elements
Labelling
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)
