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 | VERSANT HCV RNA 3.0 ASSAY (BDNA) |
Generic Name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
Regulation Number | 866.3170 |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC. 725 POTTER STREET BERKELEY, CA 94710 |
PMA Number | P020022 |
Supplement Number | S008 |
Date Received | 04/10/2009 |
Decision Date | 05/01/2009 |
Withdrawal Date
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02/26/2015 |
Product Code |
MZP |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF AN INCOMING QUALITY CONTROL STEP. |
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