General Information
Version
1.0
Revision date
2020-08-25
Product name
Pathonorm L
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 an animal- based control produced from blood collected from veterinary- certified healthy animals at Norwegian facilities
Further information
which are government approved according to EU-regulation of Directive 64/433/EU. All human additives used in this product are tested by CE- marked or FDA- approved methods to be negative for HBs antigen, HIV p24- antigen, HIV I, II and HCV antibodies. However, since no method can completely exclude the presence of infectious agents, normal laboratory precautions should be taken as for potential infectious material.
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.
