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.
| Device | Abbott Real Time CMV Amplification Reagent Kit / CMV Control Kit / CMV Calibrator Kit. |
| Classification Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Generic Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Applicant | ABBOTT MOLECULAR |
| Date Received | 2017-06-27 |
| Decision Date | 2017-09-01 |
| PMA | P160044 |
| Supplement | S001 |
| Product Code | PAB |
| Advisory Committee | Microbiology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT MOLECULAR 1300 East Touhy Avenue des Plaines, IL 60018 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P160044 | | Original Filing |
| S005 |
2022-12-20 |
30-day Notice |
| S004 |
2022-05-19 |
30-day Notice |
| S003 |
2021-02-05 |
30-day Notice |
| S002 |
2019-04-10 |
30-day Notice |
| S001 |
2017-06-27 |
135 Review Track For 30-day Notice |
NIH GUDID Devices