In Vitro Diagnostic Directive 98/79/EC

Annex II list B

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

Serology:
- anti-Duffy
- anti-Kidd
- irregular anti-erythrocytic antibodies

Virology:
- Rubella Infections
- CMV Infections
- Bacteriological infections
- Toxoplasmosis
- Chlamydia

Hereditary disease:
- phenylketonuria

HLA tissue groups:
- DR, A, B

Tumoral marker:
- PSA

Risk of trisomy 21 (including software)

Self-testing devices for the measurement of blood sugar