COBAS AMPLIPREP/COBAS TAQMAN CMV TEST
FDA premarket approval P110037/S001 · decided 2012-09-05
Approval details
- PMA number
- P110037
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COBAS AMPLIPREP/COBAS TAQMAN CMV TEST
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Applicant
- Roche Molecular Systems, Inc.
- Date received
- 2012-08-07
- Decision date
- 2012-09-05
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- PAB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR A CHANGE TO THE TEST DEFINITION FILE (TDF). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COBAS AMPLIPREP/COBAS TAQMAN CMV TEST AND IS INDICATED FOR: COBAS AMPLIPREP/COBAS TAQMAN CMV TEST THE COBAS AMPLIPREP/ COBAS TAQMAN CMV TEST IS AN IN VITRO NUCLEIC ACID AMPLIFICATION TEST FOR THE QUANTITATIVE MEASUREMENT OF CYTOMEGALOVIRUS (CMV) DNA INHUMAN EDTA PLASMA USING THE COBAS AMPLIPRCP INSTRUMENT FOR AUTOMATED SPECIMEN PROCESSING AND THE COBAS TAQMAN ANALYZER OR THE CO
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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 |