| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | Alinity m HCV |
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| Generic Name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
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| Applicant | Abbott Molecular, Inc.
1300 E. Touhy Avenue
Des Plaines, IL 60018 |
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| PMA Number | P190025 |
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| Date Received | 09/30/2019 |
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| Decision Date | 03/23/2020 |
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Reclassified Date
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12/22/2021 |
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| Product Codes |
MZP OOI |
| Docket Number | 20M-1175 |
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| Notice Date | 04/07/2020 |
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| Advisory Committee |
Microbiology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
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 human plasma (EDTA, Acid Citrate Dextrose) or serum, from HCV antibody positive individuals. The assay is intended for use as an aid in the diagnosis of active HCV infection in individuals with antibody evidence of HCV infection, and to aid in the management of patients with known active HCV infection, including SVR determination.The results from the Alinity m HCV assay must be interpreted within the context of all relevant clinical and laboratory findings.The Alinity m HCV assay is not intended to be used in screening blood, plasma, serum, tissue or tissue donors for HCV. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Supplements: |
S003 S001 S002 S004 S005 S006 |
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