| 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 HBV |
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| Generic Name | Hepatitis Viral B DNA Detection |
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| Applicant | Abbott Molecular, Inc.
1300 E Touhy Ave
Des Plaines, IL 60018 |
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| PMA Number | P200013 |
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| Date Received | 03/02/2020 |
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| Decision Date | 08/29/2020 |
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| Product Code |
MKT |
| Docket Number | 20M-1830 |
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| Notice Date | 09/30/2020 |
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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 HBV. The Alinity m HBV assay is an in vitro polymerase chain reaction (PCR) with fluorescent labeled probes assay for use with the automated Alinity m System to quantitate Hepatitis B Virus (HBV) DNA in human plasma and serum. The Alinity m HBV assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. The results from the Alinity m HBV assay must be interpreted within the context of all relevant clinical and laboratory findings.This assay is not intended to be used in screening blood, blood products, or cell, tissue, and cellular and tissue-based products (HCT/Ps), or as a diagnostic test to confirm the presence of HBV infection. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011
S012 S013 S014 S015 S017 S018 S019 S020 S021 S022 |
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