In Vitro Diagnostic Directive 98/79/EC

Annex II list A

The following IVD products fall under Annex II list A of the European Union In Vitro Diagnostic Directive (98/79/EC) and require a Notified Body such as TÜV SÜD Product Service.

Blood Group Serology:
- ABO System
- Rhesus (C, c, D, E, e)
- anti-Kell

Virology:
- HIV Infections (HIV I and II)
- HTLV I and II Infections
- Hepatitis Infections (HBV, HCV, HDV, not HAV)