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Notification

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  Body (History):

BSI
Kitemark House, Maylands Avenue,
Hemel Hempstead, Hertfordshire HP2 4SQ
Country : United Kingdom

Phone : +44 (0) 8450 765600
Fax : +44 (0) 8450 765601

Email : testing.services@bsigroup.com
Website : www.bsigroup.com

Notified Body number : 0086

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

Last update : 29/03/2010
 

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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 : 24/08/2010
Products Procedures Articles/Annexes Limitations
*IVD 0100 - Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups
 
   - *IVD 0101 - ABO system
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
   - *IVD 0102 - Rhesus (C, c, D, E, e)
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
   - *IVD 0103 - Anti-Kell
Full quality assurance system
EC type-examination
Production quality assurance
Annex IV
Annex V
Annex VII
 
*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
Production quality assurance
Annex IV
Annex V
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 0301 - Anti-Duffy and anti-Kidd
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
   - *IVD 0302 - Irregular anti-erythrocytic antibodies
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
   - *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 0304 - Hereditary disease: phenylketonuria
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 0306 - HLA tissue groups: DR, A, B
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
   - *IVD 0307 - Tumoral marker: PSA
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
   - *IVD 0308 - Risk of trisomy 21 (incl. software)
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex IV
Annex V
Annex VI
Annex VII
 
   - *IVD 0309 - Device for self-diagnosis: device for the measurement of blood sugar
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
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex III
Annex IV
Annex V
Annex VI
Annex VII
 
   - *IVD 0402 - Haematology
EC declaration of conformity
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex III
Annex IV
Annex V
Annex VI
Annex VII
 
   - *IVD 0403 - Immunology
EC declaration of conformity
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex III
Annex IV
Annex V
Annex VI
Annex VII
 
   - *IVD 0405 - Pregnancy and ovulation
EC declaration of conformity
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex III
Annex IV
Annex V
Annex VI
Annex VII
 
   - *IVD 0406 - Specimen receptacles
EC declaration of conformity
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Annex III
Annex IV
Annex V
Annex VI
Annex VII
 
 
Horizontal technical competence Limitations
*MDS 7206 - IVDs in sterile condition  
*MDS 7208 - IVDs utilising nanomaterials  
*MDS 7209 - IVDs utilising biological active coating and/or material  
*MDS 7210 - IVDs utilising material of human origin  
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