|
Device | ABBOTT REALTIME HCV GENOTYPE II |
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 | S010 |
Date Received | 12/16/2015 |
Decision Date | 03/07/2016 |
Reclassified Date
|
12/22/2021 |
Product Code |
OBF |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revisions to the application specification file for changes to the liquid level sense and pipette aspiration/dispense volumes during the sample preparation extraction process. |