ABBOTT REALTIME CMV
FDA premarket approval P160044 · decided 2017-05-18
Approval details
- PMA number
- P160044
- Trade name
- ABBOTT REALTIME CMV
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Applicant
- Abbott Molecular
- Date received
- 2016-10-04
- Decision date
- 2017-05-18
- Days to decision
- 226 days
- Decision code
- APRL
- Product code
- PAB
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Des Plaines, IL
- Statement
- 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 mu
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