Products for immune haematological testing and tissue typing: | Annex of Directive 98/79/EC | Responsibility |
---|---|---|
   Blood groups of the AB0 system1, 2 | IIa | PEI |
   Blood groups of the Rhesus system (C, c, D, E, e)1, 2 | IIa | PEI |
   Blood groups of the Kell system1, 2 | IIa | PEI |
   Blood groups of the Duffy and the Kidd system1, 2 | IIb | PEI |
   Irregular anti-erythrocyte antibodies1, 2 | IIb | PEI |
   Markers for HLA 3 typing, markers DR, A and B1, 2 | IIb | PEI |
Products for infection testing: | Â | Â |
   Markers of HIV4 infection (HIV-1 and HIV-2)1, 2 | IIa | PEI |
   HTLV-I5 und HTLV-II1, 2 | IIa | PEI |
   Hepatitis B, C und D1, 2 | IIa | PEI |
   Congentital infection with rubella1, 2 | IIb | PEI |
   Congenital infection with toxoplasma1, 2 | IIb | PEI |
   CMV1, 2, 6 | IIb | PEI |
   Chlamydia1, 2 | IIb | PEI |
Other products: | Â | Â |
   Tumor marker PSA1, 7 | IIb | BfArM |
   Hereditary diseases phenylketonuria and |  |  |
   Down syndrome (trisomy 21, including software)1 | IIb | BfArM |
Products for self testing: | Â | Â |
   Systems for measurement of blood glucose1 | IIb | BfArM |