|
Device | CERVISTA HPV HR, GENFIND DNA EXTRACTION KIT |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | HOLOGIC, INC. 250 CAMPUS DRIVE MARLBOROUGH, MA 01750 |
PMA Number | P080014 |
Supplement Number | S015 |
Date Received | 12/19/2012 |
Decision Date | 04/18/2013 |
Withdrawal Date
|
04/19/2023 |
Product Code |
MAQ |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MINOR LABELING CHANGE IN THE CERVISTA OPERATOR¿S MANUAL. |
Post-Approval Study | Show Report Schedule and Study Progress |