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 ...

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

Appendix II DEVICE MASTER FILE FOR MEDICAL DEVICES OTHER THAN IN VITRO DIAGNOSTIC ME ...

1.8 Domestic price of the device in the currency followed in the country of origin. ...

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