General Information
Version
1.0
Revision date
2018-03-14
Product name
Reagent 2
Icons in SDS
Company Information
company name
Rossix AB
e-mail address of the competent person responsible for the Safety Data Sheet
info@rossix.com
GHS Information
Signal word
Not applicable
Section 2
SECTION 2: Hazards identification
1272/2008 Classification of the substance or mixture
Hazard pictograms
Not applicable
Signal word
Not applicable
Hazard statements
Not applicable
2.3 Other hazards
This product contains purified human coagulation factors isolated from human plasma. Each donor unit used in the preparation has tested negative (using FDA approved methods) for the presence of Hepatitis B surface antigen and antibodies against Hepatitis C, HIV 1 and 2. This product contains bovine thrombin. This product contains bovine serum albumin (BSA). All donor animals are from BSE- and TSE-free livestock. Donor animals have been subjected to veterinary examination before and after donation, determining that the animals are indeed free of infectious materials. Although this product has been thoroughly tested, biological materials should always be handled as potentially infectious as a precaution.
2.1 Classification of the substance or mixture
Upon assessment, this mixture is not classified as hazardous according to 1272/2008.
