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.
NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.
WITHDRAWN
SRPS EN 376:2008
95.99
Withdrawal of Standard
Jun 28, 2011
WITHDRAWN
SRPS EN ISO 18113-4:2011