The following data is part of a De Novo classification by Meridian Bioscience, Inc. with the FDA for Alethia Cmv Dna Amplification Assay, Alethia Cmv External Control Kit.
| DeNovo ID | DEN180040 |
| Device Name: | Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit |
| Classification | Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection |
| Applicant | Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati, OH 45244 |
| Contact | Jack Rogers |
| Product Code | QDZ |
| CFR Regulation Number | 866.3181 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Direct |
| Date Received | 2018-07-30 |
| Decision Date | 2018-11-30 |
| Reclassification Order: | Reclassification Order |