COBAS AMPLIPREP/COBAS TAQMAN HCV TEST/COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM, V2.0
FDA premarket approval P060030/S024 · decided 2012-09-18
Approval details
- PMA number
- P060030
- Supplement
- S024
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COBAS AMPLIPREP/COBAS TAQMAN HCV TEST/COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM, V2.0
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2011-12-12
- Decision date
- 2012-09-18
- Days to decision
- 281 days
- Decision code
- APPR
- Product code
- MZP
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR THE MANUFACTURING CHANGES TO THE DNA SYNTHESIZER INSTRUMENT PLATFORM FOR THE VIALED MASTER MIX AND PROBE REAGENT COMPONENTS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| cobas® BV/CV (K260021) | Roche Molecular Systems, Inc. | 2026-07-16 |
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| cobas liat CT/NG/MG nucleic acid test (K253759) | Roche Molecular Systems, Inc. | 2026-05-15 |
| cobas liat CT/NG nucleic acid test (K253756) | Roche Molecular Systems, Inc. | 2026-05-15 |
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| cobas CMV (K252481) | Roche Molecular Systems, Inc. | 2025-11-03 |
| cobas HCV (K252484) | Roche Molecular Systems, Inc. | 2025-11-03 |
| cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (K243455) | Roche Molecular Systems, Inc. | 2025-07-31 |