Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 IMMUNOASSAY (COBAS E 411) AND PRECICONTROL ANTI-HCV
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP090007
Supplement NumberS011
Date Received11/30/2012
Decision Date12/20/2012
Reclassified Date 12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
TRANSFER OF THE FINAL PACKAGING PROCESS TO A DIFFERENT LINE WITHIN THE MANNHEIM, GERMANY SITE AND TO CHANGE THE BOX AND SPACER ELEMENT SIZE, MAIN AND SIDE LABELSIZE AND LABEL LAYOUT.
-
-