|
Device | Aptima HCV Quant Dx Assay |
Generic Name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
Regulation Number | 866.3170 |
Applicant | HOLOGIC, INC. 10210 Genetic Center Dr SAN DIEGO, CA 92121 |
PMA Number | P160023 |
Supplement Number | S001 |
Date Received | 08/28/2017 |
Decision Date | 02/23/2018 |
Reclassified Date
|
12/22/2021 |
Product Code |
MZP |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the use of the Aptima HCV Quant Dx Assay on the Panther System with the attachment of the Panther Fusion Module. The changes being approved include the addition of new hardware and updated software. |