F1ANNEX COMMON TECHNICAL SPECIFICATIONS (CTS) FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES

Annotations:

3. COMMON TECHNICAL SPECIFICATIONS (CTS) FOR PRODUCTS REFERRED TO IN ANNEX II, LIST A OF DIRECTIVE 98/79/EC

Qualifications:

Clinical samples

10 % of the test population

Neonatal specimens

> 2 % of the test population

ABO samples

> 40 % A, B positives

‘weak D’

> 2 % of RH1 (D) positives