Stability (excluding specimen stability): This section should describe claimed shelf ...

16.0 Claimed Shelf life: This section should provide information on stability testing ...

16.0 Claimed Shelf life: This section should provide information on stability testing ...

7.7 Animal studies: (i) Where studies in an animal model have been undertaken to prov ...

7.7 Animal studies: (i) Where studies in an animal model have been undertaken to prov ...

Animal studies: (i) Where studies in an animal model have been undertaken to provide ...

1.1 Introductory descriptive information on the in vitro diagnostic medical device, t ...

DEVICE MASTER FILE FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES 1.0 Executive Summary An ...