BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA)
FDA premarket approval P020022/S002 · decided 2005-03-25
Approval details
- PMA number
- P020022
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BAYER 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
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date received
- 2005-01-31
- Decision date
- 2005-03-25
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Berkeley, CA
- Statement
- APPROVAL FOR ADDITION OF LABORATORY INFORMATION SYSTEM INTERFACE (VERSION 1.0) TO THE BAYER SYSTEM 340 BDNA ANALYZER DMS.
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