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 ...

17.0 In use stability: This section should provide information on in use stability st ...

2. Bio-compatibility tests data, Report of bio-compatibility tests along with rationa ...

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

14.0 Definition of Assay Cut-off: This section should provide a summary of analytical ...