COBAS TAQMAN HBV TEST
FDA premarket approval P050028 · decided 2008-09-04
Approval details
- PMA number
- P050028
- Trade name
- COBAS TAQMAN HBV TEST
- Generic name
- Hepatitis Viral B DNA Detection
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2005-08-02
- Decision date
- 2008-09-04
- Days to decision
- 1129 days
- Decision code
- APRL
- Product code
- MKT
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM. THIS DEVICE IS INDICATED FOR: THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATION OF HEPATITIS B VIRUS (HBV) DNA IN HUMAN SERUM OR PLASMA (EDTA), USING THE HIGH PURE VIRAL NUCLEIC ACID KIT FOR MANUAL SPECIMEN PREPARATION AND THE COBAS TAQMAN 48 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION. THE TEST IS INTENDED FOR USE AS AN AID IN THE MANAGEMENT
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510(k) clearances by this applicant
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|---|---|---|
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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 |