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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceAlinity m HBV
Generic Namehepatitis viral b dna detection
Applicant
Abbott Molecular, Inc.
1300 e touhy ave
des plaines, IL 60018
PMA NumberP200013
Supplement NumberS002
Date Received01/27/2021
Decision Date04/26/2021
Product Code MKT 
Advisory Committee Microbiology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the design change to the access hole diameter of the Alinity m Universal Sample Rack Retention Bar.
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