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. |
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Device | ELECSYS ANTI-HCV IMMUNOASSAY (COBAS E 411) AND PRECICONTROL ANTI-HCV |
Generic Name | Assay, enzyme linked immunosorbent, hepatitis c virus |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 |
PMA Number | P090007 |
Supplement Number | S011 |
Date Received | 11/30/2012 |
Decision Date | 12/20/2012 |
Reclassified Date
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12/22/2021 |
Product Code |
MZO |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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