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Found : 17
  Body (History):

TURKISH STANDARDS INSTITUTION (TSE)
Necatibey Cad. No. 112, 06100 Bakanliklar
Ankara
Country : Turkey

Phone : +90 312 416 64 82
Fax : +90 312 416 66 17

Email : mcetin@tse.org.tr
Website : www.tse.org.tr

Notified Body number : 1783

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14

Last update : 06/08/2010
 

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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 : 07/03/2012                 Version(s): 1 2

Products Procedures Articles/Annexes Limitations
*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
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
   - *IVD 0302 - Irregular anti-erythrocytic antibodies
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
   - *IVD 0303 - Congenital infections: rubella, toxoplasmosis
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
   - *IVD 0304 - Hereditary disease: phenylketonuria
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
   - *IVD 0305 - Human infections: cytomegalovirus, chlamydia
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
   - *IVD 0306 - HLA tissue groups: DR, A, B
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
   - *IVD 0307 - Tumoral marker: PSA
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
   - *IVD 0308 - Risk of trisomy 21 (incl. software)
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
   - *IVD 0309 - Device for self-diagnosis: device for the measurement of blood sugar
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex IV
Annex VII
 
*IVD 0400 - Devices for self-testing
 
   - *IVD 0401 - Clinical chemistry
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0402 - Haematology
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0403 - Immunology
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0404 - Molecular biology
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0405 - Pregnancy and ovulation
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
   - *IVD 0406 - Specimen receptacles
EC declaration of conformity
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex IV
Annex VII
 
 
Horizontal technical competence Limitations
*MDS 7206 - IVDs in sterile condition  
*MDS 7207 - IVDs utilising micromechanics  
*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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