DEN180040 is an FDA 510(k) submission for the Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit. This device is classified as a Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection (Class II - Special Controls, product code QDZ).
Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Not Cleared (DENG) decision on November 30, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3181. The Device Is A Qualitative, In Vitro Diagnostic Test For The Direct Detection Of Cytomegalovirus (cmv) Dna In Saliva From Newborn Babies..
| 510(k) Number | DEN180040 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | July 30, 2018 |
| Decision Date | November 30, 2018 |
| Days to Decision | 123 days |
| Submission Type | Direct |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | QDZ — Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3181 |
| Definition | The Device Is A Qualitative, In Vitro Diagnostic Test For The Direct Detection Of Cytomegalovirus (cmv) Dna In Saliva From Newborn Babies. |