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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.
 
DeviceELECSYS ANTI-HCV ON COBAS E 411
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
Regulation Number866.3169
ApplicantRoche Diagnostics Corp.
9115 Hague Rd.
Indianapolis, IN 46250
PMA NumberP090007
Supplement NumberS007
Date Received01/31/2012
Decision Date12/20/2012
Reclassified Date12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement Type135 Review Track For 30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A TRANSFER OF A PORTION OF THE MANUFACTURING OPERATIONS FOR THE BULK SOLUTIONS OF REAGENTS R1 AND R2, AS WELL AS BULK SOLUTIONS OF PRETREATMENT REAGENTS TO NEWLY CONSTRUCTED MANUFACTURING SPACE.
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