General Information
Version
04 - Revision
Revision date
2023-04-03
Product name
APC-R Dilution Plasma
1.2.1 Relevant identified uses
Diagnostic reagent Kit component
Emergency telephone
+41 44 251 51 51, +41 44 251 66 66
Icons in SDS
Company Information
company name
Pentapharm AG
e-mail address of the competent person responsible for the Safety Data Sheet
pentapharm@pentapharm.com
GHS Information
Signal word
Void
Section 2
SECTION 2: Hazards identification
Classification of the substance or mixture
Hazard pictograms
Void
Signal word
Void
Hazard statements
Void
2.3 Other hazards
Reagent 4 (55025R4) contains Human plasma (50 – 100%). Each donor unit used in the preparation of Dilution Plasma (R4) has been tested for antibodies against HIV Typ 1 and 2, Hepatitis C-virus antibodies, Treponema pallidum antibodies as well as Hepatitis B surface antigen and Hepatitis C genome by PCR. The tests used are all CE certified tests according to list A of the European Directive for IVD (98/79/EC) and are under supervision by the responsible European governmental authority. The plasmas were found to be negative on the test parameters. However, since no test can completely rule out the presence of blood borne diseases these control plasmas have to be handled as potentially infectious material.
PBT Substances
According to current knowledge, the product contains no PBT substance
vPvB Substances
According to current knowledge, the product contains no vPvB substance Determination of endocrine-disrupting properties Taking into account the current state of scientific knowledge, no data on endocrine disrupting properties of the product are available.
2.1 Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008 The product is not classified, according to the CLP regulation.
