1 Scope
This document specifies requirements for information supplied by the manufacturer
of in vitro diagnostic (IVD) reagents, calibrators and controls intended for professional
use.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to
the instructions for use.
This document does not apply to:
-
a) IVD instruments or equipment;
-
b) IVD reagents for self-testing.