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 HBV assay |
Generic Name | Hepatitis Viral B DNA Detection |
Applicant | Abbott Molecular, Inc. 1300 E Touhy Ave Des Plaines, IL 60018 |
PMA Number | P200013 |
Supplement Number | S007 |
Date Received | 02/22/2022 |
Decision Date | 06/28/2022 |
Product Code |
MKT |
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 an update to the Amp-Detect Motion Profile configurable parameters stored in the Alinity m System Amp-Detect Units (ADU). |
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