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Notification

Found : 11
  Body (History):

POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. (PCBC)
ul. Klobucka 23A
02-699 Warsawa
Country : Poland

Phone : +48 (22) 464 52 01
Fax : +48 (22) 647 12 22

Email : polskie.centrum@pcbc.gov.pl
Website : www.pcbc.gov.pl

Notified Body number : 1434

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17

Last update : 25/08/2006
 

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Some information about the accreditation details are available in the PDF
Legislation
98/79/EC In vitro diagnostic medical devices     (History)
Last update : 25/08/2006                 Version(s): 1 2

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  
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  
devices for self-testing: pregnancy, ovulation and drug tests
EC declaration of conformity
Full quality assurance system
Annex III
Annex IV
 
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