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Notification

Found : 15
 
  Body :

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

Phone : +39 06 49906146
Fax : +39 06 49903150

Email : roberta.marcoaldi@iss.it
Website : www.iss.it

Notified Body number : 0373

 

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 approval date : 19/04/2016                 Version(s): 1 2

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
EC type-examination
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex V
Annex IV
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
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex V
Annex VI
Annex IV
Annex VII
 
   - *IVD 0305 - Human infections: cytomegalovirus, chlamydia
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex V
Annex VI
Annex IV
Annex VII
 
   - *IVD 0307 - Tumoral marker: PSA
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex V
Annex VI
Annex IV
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