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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceAlinity m HBV
Generic Namehepatitis viral b dna detection
Applicant
Abbott Molecular, Inc.
1300 e touhy ave
des plaines, IL 60018
PMA NumberP200013
Date Received03/02/2020
Decision Date08/29/2020
Product Code MKT 
Docket Number 20M-1830
Notice Date 09/30/2020
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements:  
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