CEN/TC 140
| Project No. | EN 376:2002 |
|---|---|
| Title | 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. |
| Registration number (WIID) | 5099 |
| 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. |
| Status | Atcelts |
| ICS group | 11.100 |