Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S013 |
Date Received | 04/19/2019 |
Decision Date | 05/21/2019 |
Reclassified Date
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12/22/2021 |
Product Code |
MZP |
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 Remove QC release testing for a device ancillary kit. |
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