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FDAMarket Authorization
[PMA Approved] Alinity m HCV — Abbott Molecular, Inc. — P190025
Mar 23, 2020
Decision Date: 2020-03-23Published: 2020-03-23Captured: 2026-02-20Abbott Molecular, Inc.Device: Alinity m HCVProduct Code: MZP
FDA approved PMA P190025 (decision: APRL). Alinity m HCV by Abbott Molecular, Inc..
- •Trade name: Alinity m HCV
- •Applicant: Abbott Molecular, Inc.
- •Decision: APRL
- •Product code: MZP
Decision:APRL
Device Class:2
Advisory Committee:MI
Statement/Summary
Approval for the Alinity m HCV. The assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for both the detection and quantitation of hepatitis C virus (HCV) RNA, in hu...
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