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 | AMPLICOR HCV TEST |
Generic Name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
Regulation Number | 866.3170 |
Applicant | Roche Molecular Systems, Inc. 4300 HACIENDA DR. PLEASANTON, CA 94588-0900 |
PMA Number | P000010 |
Supplement Number | S016 |
Date Received | 03/09/2010 |
Decision Date | 04/07/2010 |
Withdrawal Date
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06/30/2014 |
Product Code |
MZP |
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 CHANGES TO THE CIP PROCESS FOR THE BULK FORMULATION TANKS AND THEIR ASSOCIATED FILLING TRANSFER LINES, AND MINOR MODIFICATIONS TO THE HOPPER EQUIPMENT USED IN THE FORMULATION OF BULK REAGENTS FOR THE DEVICE. |
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