European Commission - Enterprise and Industry

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Notification

Found : 11
 
  Body (History):

VTT (TECHNICAL RESEARCH CENTRE OF FINLAND)
PL 1300
33101 Tampere
Country : Finland

Phone : +358:20:722 111
Fax : +358:20:722 6251

Email : -
Website : -

Notified Body number : 0537

Version(s): 1 2 3

Last update : Unknown (Notifications pre-dating 2006 are not available in these lists)
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
98/79/EC In vitro diagnostic medical devices    
Last update : Unknown (Notifications pre-dating 2006 are not available in these lists)
Products Procedures Articles/Annexes Limitations
Reagents and reagent products, including related calibrators and control materials, for controlling the following blood groups: ABO system, Rhesus (C, c, D, E, e), anti-Kell
Full quality assurance system Annex IV  
Reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies
Full quality assurance system Annex IV  
Reagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B
Full quality assurance system Annex IV  
Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-Kidd
Full quality assurance system Annex IV  
Reagents and reagent products, including related calibrators and control materials, for determining the following hereditary disease: phenylketonuria
Full quality assurance system Annex IV  
Reagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydia
Full quality assurance system Annex IV  
Reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA
Full quality assurance system Annex IV  
Reagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosis
Full quality assurance system Annex IV  
Reagents and reagent products, including related calibrators and control materials, for the 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
Full quality assurance system Annex IV  
Self diagnosis devices for determining pregnancy and ovulation
EC declaration of conformity
Full quality assurance system
Annex III
Annex IV
 
The following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar
Full quality assurance system Annex IV