|
Device | Abbott RealTime HBV Assay |
Generic Name | Hepatitis Viral B DNA Detection |
Applicant | ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 |
PMA Number | P080026 |
Supplement Number | S023 |
Date Received | 11/16/2020 |
Decision Date | 12/04/2020 |
Product Code |
MKT |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement the implementation of an in-process QC test |