General Information
Product name
ROTROL N
1.2.1 Relevant identified uses
In vitro blood coagulation diagnostic •
Manufacturer Name
Tem Innovations GmbH
Icons in SDS
Company Information
company name
TEM Systems, Inc
e-mail address of the competent person responsible for the Safety Data Sheet
support@roteminc.com
Section 2
SECTION 2: Hazards identification
Hazard statements
Human source material. Handle as though capable of transmitting infectious agents. • Information regarding particular dangers for man and environment: Caution! May cause irritation. May cause central nervous system effects. This product is a substance of human origin. Even though tests are negative for infectious diseases, this product should be handled as a potentially infectious biological material. It should be handled only by competent personnel, within a controlled environment. Target organs: none. The starting material for each batch of ROTROL N was tested using appropriate methods and found non-reactive with HBsAg and antibody-negative for HIV1, HIV2, and HCV. It should be noted that there is no known test method that is able to provide information with 100% certainty that products obtained from human blood are free from hepatitis, AIDS or other infectious diseases. This product should be seen as potentially infectious just as all materials of human origin. •
Classification system
The classification was made according to the latest editions of international substances lists, and further expanded upon from company and literature data. • NFPA ratings (scale 0-4) Health = 0 0 Fire = 0 0 Reactivity = 0
