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 HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 |
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 | S006 |
Date Received | 01/18/2006 |
Decision Date | 02/17/2006 |
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 IN THE TESTING PARAMETERS USED TO CONSTRUCT A SPECIFIC CONJUGATE, AND AN UPGRADE IN THE HPLC SOFTWARE. |
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