Factor XIa Control

Rossix AB

Revision date : 2013-03-01

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Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

25322-68-3

Name of the chemical

polyethyleneglycol

Concentration

N/A

General Information

Revision date

2013-03-01

Product name

Factor XIa Control

1.2.1 Relevant identified uses

Product for In Vitro Research Use

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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 The Factor XIa Control is not a hazardous mixtures according to Regulation (EC) No 1272/2008 The Factor XIa Control is not classified as dangerous according to Directive 67/548/EEC

2.3 Other hazards

Biological Risk The product contains a purified human coagulation factor 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.

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