Products |
Procedures |
Articles/Annexes |
Limitations |
*IVD 0200 - Reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of
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- *IVD 0201 - HIV infection (HIV 1 and 2)
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EC declaration of conformity EC declaration of conformity (full quality assurance system) |
Annex III Annex IV |
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- *IVD 0202 - HTLV I and II
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EC declaration of conformity EC declaration of conformity (full quality assurance system) |
Annex III Annex IV |
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- *IVD 0203 - Hepatitis B, C and D
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EC declaration of conformity EC declaration of conformity (full quality assurance system) |
Annex III Annex IV |
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*IVD 0300 - Reagents, reagent products and devices for self-diagnosis, including related calibrators and control materials, for determining, detection, quantification, diagnosing, evaluating
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- *IVD 0303 - Congenital infections: rubella, toxoplasmosis
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EC declaration of conformity (full quality assurance system) |
Annex IV |
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- *IVD 0304 - Hereditary disease: phenylketonuria
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EC declaration of conformity (full quality assurance system) |
Annex IV |
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- *IVD 0305 - Human infections: cytomegalovirus, chlamydia
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EC declaration of conformity (full quality assurance system) |
Annex IV |
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- *IVD 0307 - Tumoral marker: PSA
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EC declaration of conformity (full quality assurance system) |
Annex IV |
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- *IVD 0308 - Risk of trisomy 21 (incl. software)
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EC declaration of conformity (full quality assurance system) |
Annex IV |
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- *IVD 0309 - Device for self-diagnosis: device for the measurement of blood sugar
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EC declaration of conformity (full quality assurance system) |
Annex IV |
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*IVD 0400 - Devices for self-testing
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- *IVD 0401 - Clinical chemistry
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EC declaration of conformity EC declaration of conformity (full quality assurance system) |
Annex III Annex IV |
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- *IVD 0403 - Immunology
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EC declaration of conformity EC declaration of conformity (full quality assurance system) |
Annex III Annex IV |
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- *IVD 0404 - Molecular biology
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EC declaration of conformity EC declaration of conformity (full quality assurance system) |
Annex III Annex IV |
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- *IVD 0405 - Pregnancy and ovulation
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EC declaration of conformity EC declaration of conformity (full quality assurance system) |
Annex III Annex IV |
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- *IVD 0406 - Specimen receptacles
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EC declaration of conformity EC declaration of conformity (full quality assurance system) |
Annex III Annex IV |
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Horizontal technical competence |
Limitations |
*MDS 7205 - IVDs incorporating software / utilising software / controlled by software |
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*MDS 7206 - IVDs in sterile condition |
Including aseptic processing, ethylene oxide gas sterilisation (EOG), low temperature steam and formaldehyde sterilisation, moist heat sterilisation, radiation sterilisation (gamma, x-ray, electron beam), others (need to be specified) |
*MDS 7210 - IVDs utilising material of human origin |
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