|
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 | S017 |
Date Received | 05/25/2018 |
Decision Date | 06/21/2018 |
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 Modify the manufacturing and QC testing for a kit component and tighten an incoming reagent specification. |