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 | Alinity m HR HPV Assay |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | Abbott Molecular, Inc 1300 East Touhy Avenue Des Plaines, IL 60018 |
PMA Number | P230003 |
Supplement Number | S002 |
Date Received | 12/20/2023 |
Decision Date | 01/20/2024 |
Product Code |
MAQ |
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 changes for in-process manufacturing parameters |
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