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  Body (History):

LLOYD'S REGISTER QUALITY ASSURANCE LTD (0088)
Hiramford Middlemarch Office Village Siskin Drive
Coventry CV3 4FJ
Country : United Kingdom

Phone : +44(0)24 7688 2399
Fax : +44(0)24 7630 6055

Email : ecdirectives@lrqa.com
Website : -

Notified Body number : 0088

Version(s): 1 2 3 4 5 6 7

Last update : 27/06/2006
 

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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 :
Products Procedures Articles/Annexes Limitations
All Annex II list A devices which have existing notified body (NB) certification via their original manufacturer
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
All Annex II list B devices which have existing notified body (NB) certification via their original manufacturer
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
All self-test devices which have existing notified body (NB) certification via their original manufacturer
EC declaration of conformity
Full quality assurance system
Production quality assurance
Annex III
Annex IV
Annex VII
 
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
Production quality assurance
Annex IV
Annex VII
 
Reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
Reagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
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
Production quality assurance
Annex IV
Annex VII
 
Reagents and reagent products, including related calibrators and control materials, for determining the following hereditary disease: phenylketonuria
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
Reagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydia
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
Reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
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
Production quality assurance
Annex IV
Annex VII
 
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
Production quality assurance
Annex IV
Annex VII
 
Self test devices for urinalysis, endocrinology, general chemistry, general immunology and haematology
EC declaration of conformity
Full quality assurance system
Production quality assurance
Annex III
Annex IV
Annex VII
 
The following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar
Full quality assurance system
Production quality assurance
Annex IV
Annex VII
 
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