COBAS TAQMAN HBV TEST
FDA premarket approval P050028/S002 · decided 2008-11-25
Approval details
- PMA number
- P050028
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COBAS TAQMAN HBV TEST
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2008-10-31
- Decision date
- 2008-11-25
- Days to decision
- 25 days
- Decision code
- OK30
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- REPLACEMENT OF TETRAZOLE, AN ACTIVATOR USE DIN THE AUTOMATED DNA SYNTHESIS OF RMS OLIGONUCLEOTIDES USE IN THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM WITH THE ACTIVATOR 4,5 DICYANOIMIDAZOLE (DCI).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| cobas® BV/CV (K260021) | Roche Molecular Systems, Inc. | 2026-07-16 |
| cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems (K260917) | Roche Molecular Systems, Inc. | 2026-07-08 |
| 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 |
| cobas liat Bordetella panel nucleic acid test (K243753) | Roche Molecular Systems, Inc. | 2025-11-20 |
| 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 |