BAS EN 376:2004
Information supplied by the manufacturer with in vitro diagnostic reagents for self-testing
General Information
Status: Withdrawn
No. of pages: 18
Language: English
Edition: 1.
Adoption method: Endorsment
Publication date: 28.12.2004
Technical committee:
Directive:
98/79/EC, In vitro diagnostic medical devices
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Abstract
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.
Lifecycle
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Original document and degree of correspondence
- EN 376:2002, identical