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Categorization of In-vitro Diagnostic
Devices
The in-vitro diagnostics are
categorizied as follows:
Devices according to Annex
II, List A:
Reagents and reagent products, including related calibrators and control materials, for:
- determining the following
blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell
- detection, confirmation and
quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV
I and II, and hepatitis B, C and D.
Devices according to Annex
II, List B:
Reagents and reagent products, including related calibrators and control materials, for:
- determining the blood
groups anti-Duffy and anti-Kidd,
- determining irregular anti-erythrocytic antibodies,
- detection and quantification of the infections rubella and toxoplasmosis,
- determining the infections cytomegalovirus and chlamydia,
- diagnosing phenylketonuria,
- determining the HLA tissue groups: DR, A, B,
- determining the tumor marker PSA,
Reagents and reagent products, including related calibrators, control materials and
software for evaluating the risk of trisomy 21,
Devices for self-diagnosis including related calibrators, control materials measurement of
blood sugar.
Products for self-testing:
Devices intended to be used by a lay user in a home environment.
Devices for performance
evaluation
All devices intended by the manufacturer to be subject to one or more performance
evaluation studies in laboratories for medical analysis or in other appropiate
environments outside his own premises.
All other in-vitro
diagnostic devices
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