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EN 376:2002

Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing EN 376:2002

Publication date:   Jan 22, 2004

General information

99.60 Withdrawal effective   Dec 15, 2009

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.100   Laboratory medicine

Buying

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Language in which you want to receive the document.

Scope

This standard specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents for use in self-testing including reagent products, calibrators, control materials and kits, which hereafter are called IVD reagents.

NOTE This standard can also be applied to accessories.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting
more

Life cycle

PREVIOUSLY

WITHDRAWN
EN 376:1992

NOW

WITHDRAWN
EN 376:2002
99.60 Withdrawal effective
Dec 15, 2009

REVISED BY

WITHDRAWN
EN ISO 18113-4:2009