|
Device | ABBOTT REALTIME HCV GENOTYPE II ASSAY |
Generic Name | Assay, genotyping, hepatitis c virus |
Regulation Number | 866.3170 |
Applicant | ABBOTT MOLECULAR 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 |
PMA Number | P120012 |
Supplement Number | S014 |
Date Received | 06/01/2016 |
Decision Date | 06/30/2016 |
Reclassified Date
|
12/22/2021 |
Product Code |
OBF |
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 bring reagent filling from an external supplier to an in-house process. |