|
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 | S017 |
Date Received | 03/28/2016 |
Decision Date | 04/12/2016 |
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 Change to consolidate the current QC testing for the Amplification Reagent Kit from two stages into a single finished kit QC stage. |