COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)
FDA premarket approval P110037 · decided 2012-07-05
Approval details
- PMA number
- P110037
- Trade name
- COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2011-10-24
- Decision date
- 2012-07-05
- Days to decision
- 255 days
- Decision code
- APRL
- Product code
- PAB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR THE COBAS AMPLIPREP/COBAS TAQMAN CMV TEST. THIS DEVICE IS INDICATED FOR: THE COBAS AMPLIPREP/COBAS TAQMAN CMV TEST IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATIVE MEASUREMENT OF CYTOMEGALOVIRUS (CMV) DNA IN HUMAN EDTA PLASMA USING THE COBAS AMPLIPREP INSTRUMENT FOR AUTOMATED SPECIMENPROCESSING AND THE COBAS TAQMAN ANALYZER OR THE COBAS TAQMAN 48 ANALYZER FOR AUTOMATED AMPLIFICATION AND DETECTION. THE COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST IS INTENDED FOR USE AS A
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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 |