General Information
Version
1.0
Revision date
2020-07-31
Product name
Seronorm Human
1.2.1 Relevant identified uses
SU20 Health services Quality control material for in-vitro diagnostics
Manufacturer Name
NO-1396
Emergency telephone
+47 66 85 89 00, +47 22 59 13 00
Icons in SDS
Company Information
company name
SERO AS
e-mail address of the competent person responsible for the Safety Data Sheet
seronorm@sero.no
GHS Information
Signal word
Not applicable
Section 2
SECTION 2: Hazards identification
No 1272/2008 Classification of the substance or mixture
2.2 Label elements
Labelling according to Regulation (EC) The product is not classified according to the No.1272/2008 CLP regulation.
Hazard pictograms
Not applicable.
Signal word
Not applicable.
Hazard statements
Not applicable
2.3 Other hazards
The material is a human- based control serum produced from blood collected from voluntary
Further information
blood donors. The material has been tested by CE- marked or FDA- approved methods to be negative for HBs antigen, HIV p24- antigen and HIV I, II and HCV antibodies. However, since no method can completely exclude the presence of infectious agents, this material should be handled as an ordinary patient sample. Contains added components of animal origin.
2.1 Classification of the substance or mixture
Classification according to Regulation (EC) The product is not classified according to the No.1272/2008 CLP regulation.