Abbott Real Time CMV Amplification Reagent Kit / CMV Control Kit / CMV Calibrator Kit.
FDA premarket approval P160044/S001 · decided 2017-09-01
Approval details
- PMA number
- P160044
- Supplement
- S001
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Abbott Real Time CMV Amplification Reagent Kit / CMV Control Kit / CMV Calibrator Kit.
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Applicant
- Abbott Molecular
- Date received
- 2017-06-27
- Decision date
- 2017-09-01
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- PAB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- Approval for changes to the polypropylene resin, cap colorant and inside diameter of the tubes and screw-caps used for storage and transport of the finished calibrators and controls, and for the master mix assembly.
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510(k) clearances by this applicant
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| simpli-COLLECT STI Test (K243410) | Abbott Molecular | 2025-01-30 |
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