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Notification

Found : 14
  Body (History):

ISTITUTO SUPERIORE DI SANITA
Viale Regina Elena, 299
00161 ROMA
Country : Italy

Phone : +39/649901
Fax : +39/64469938

Email : -
Website : -

Notified Body number : 0373

Version(s): 1 2

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

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Some information about the accreditation details are available in the PDF
Legislation
98/79/EC In vitro diagnostic medical devices    
Last update : 29/06/2011
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
 
   - *IVD 0201 - HIV infection (HIV 1 and 2)
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
   - *IVD 0202 - HTLV I and II
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
   - *IVD 0203 - Hepatitis B, C and D
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
*IVD 0300 - Reagents, reagent products and devices for self-diagnosis, including related calibrators and control materials, for determining, detection, quantification, diagnosing, evaluating
 
   - *IVD 0303 - Congenital infections: rubella, toxoplasmosis
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
   - *IVD 0305 - Human infections: cytomegalovirus, chlamydia
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
*IVD 0400 - Devices for self-testing
 
   - *IVD 0401 - Clinical chemistry
EC declaration of conformity Annex III  
   - *IVD 0402 - Haematology
EC declaration of conformity Annex III  
   - *IVD 0403 - Immunology
EC declaration of conformity Annex III  
   - *IVD 0404 - Molecular biology
EC declaration of conformity Annex III  
   - *IVD 0405 - Pregnancy and ovulation
EC declaration of conformity Annex III  
   - *IVD 0406 - Specimen receptacles
EC declaration of conformity Annex III  
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