Approval for the abbott realtime cmv test is an in vitro polymerase chain reaction (pcr) assay for the quantitation of cytomegalovirus (cmv) dna in human edta plasma. The abbott realtime cmv test is intended for use as an aid in the management of hematopoietic stem cell transplant patients who are undergoing anti-cytomegalovirus therapy. In this population, serial dna measurement can be used to assess virological response to anti-cytomegalovirus therapy. The results from the realtime cmv test must be interpreted within the context of all relevant clinical and laboratory findings. The realtime cmv test is not intended as a screening test for the presence of cmv dna in blood or blood products.
| Device | ABBOTT REALTIME CMV |
| Classification Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Generic Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Applicant | ABBOTT MOLECULAR |
| Date Received | 2016-10-04 |
| Decision Date | 2017-05-18 |
| Notice Date | 2017-06-01 |
| PMA | P160044 |
| Supplement | S |
| Product Code | PAB |
| Docket Number | 17M-3200 |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT MOLECULAR 1300 East Touhy Avenue des Plaines, IL 60018 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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