|
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 | S016 |
Date Received | 12/23/2019 |
Decision Date | 01/21/2020 |
Reclassified Date
|
12/22/2021 |
Product Code |
MZP |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to add an alternate cleaning method for the Sample Shields and Target Capture Reagent (TCR) adapters used on the Panther/Panther Fusion instruments. |