Project No.EN 375:2001
TitleThis standard specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits for professional use, which hereafter are called reagents. Note: This standard can also be applied to accessories.
Registration number (WIID)5098
ScopeThis standard specifies the requirements for the information supplied by the manufacturer of in vitro diagnostic reagents including reagent products, calibrators, control materials and kits for professional use, which hereafter are called reagents. Note: This standard can also be applied to accessories.
StatusAtcelts
ICS group01.040.11
11.100