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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.
 
DeviceABBOTT REAL TIME HCV
Generic NameAssay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Regulation Number866.3170
ApplicantABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
DES PLAINES, IL 60018
PMA NumberP100017
Supplement NumberS005
Date Received03/01/2013
Decision Date09/25/2013
Reclassified Date 12/22/2021
Product Code MZP 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN OPTIONAL EXTENDED USE FEATURE TO ALLOW PREPARED AMPLIFICATION MASTER MIX AND INTERNAL CONTROL TO BE USED A SECOND TIME WITHIN 14 DAYS OF INITIAL USE IF STORED AT -25°C TO -15°C; 2) PROCESS IMPROVEMENTS TO THE LIQUID LEVEL SENSING PERFORMED BY THE ABBOTT M2000SP INSTRUMENT; 3) THE CONVERSION OF MANUAL PLATE FILLING TO AUTOMATED PLATE FILLING; AND 4) ASSOCIATED SOFTWARE REVISIONS.
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