Note: Ingredients listed on restricted chemical lists
EC/CAS
25322-68-3
Name of the chemical
polyethyleneglycol
Concentration
N/A
General Information
Revision date
2012-09-17
Product name
Rox Factor XIa
1.2.1 Relevant identified uses
Kit for In Vitro Research Use
Emergency telephone
European Union
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
Section 2
SECTION 2: Hazards identification
Directive 67/548/EEC: Mixture Classification None of the Kit components (Reagent 1, Reagent 2, FXa Substrate and Diluent Buffer) are hazardous mixtures according to Regulation (EC) No 1272/2008 None of the Kit components (Reagent 1, Reagent 2, FXa Substrate and Diluent Buffer) are classified as dangerous according to Directive 67/548/EEC
2.3 Other hazards
Biological Risk The product contains purified human coagulation factors extracted from human plasma. Each donor unit used for the preparation has been tested by FDA approved methods for the presence of Hepatitis B surface antigen and antibodies to HIV 1 and 2 and Hepatitis C and found to be negative. Bovine Serum Albumin (BSA) were prepared from bovine plasma of Australian and New Zeeland origin and hence from countries demonstrated to be free from transmissible spongiform encephalopathies (TSEs) affecting animals, including bovine spongiform encephalopathy (BSE) and scrapie. However, no biological test may totally exclude the presence of any infectious agent. This product, as with all human based specimens, should be handled with proper laboratory safety procedures and disposal procedures to minimize the risk of transmission of infectious disease.
