COBAS AMPLIPREP/COBAS TAQMAN HBV TEST
FDA premarket approval P050028/S013 · decided 2011-02-24
Approval details
- PMA number
- P050028
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COBAS AMPLIPREP/COBAS TAQMAN HBV TEST
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2011-02-08
- Decision date
- 2011-02-24
- Days to decision
- 16 days
- Decision code
- OK30
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- ELIMINATION OF THE IN-PROCESS CHEMICAL TESTING OF THE BUFFER CONCENTRATE COMPONENT OF THE MASTER MIX USED WITH THE COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0 WITHIN THE FDA APPROVED PCR MANUFACTURING CENTER (PMC) FACILITY IN BRANCHBURG, NEW JERSEY.
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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 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 |