Question

Question No. 5
IVDs are not a medical device?
O "True"
O "False"​

Answer 1

Answer:

True . A medical device is an in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use.

Answer 2

Answer:

Flase.

In Vitro Diagnostic (IVD) tests are a subset of medical devices. In vitro diagnostic tests are used for in vitro examination of specimens derived from the human body to provide information for screening, diagnosis, or treatment monitoring purposes.