510(k) DEN180040
- Device
- Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
- Applicant
- Meridian Bioscience, Inc.
- 510(k) number
- DEN180040
- Product code
- QDZ
- Decision
- Unknown (DENG)
- Decision date
- 2018-11-30
- Date received
- 2018-07-30
- Regulation
- 866.3181
- Classification name
- Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jack Rogers
- Address
- 3471 River Hills Dr. Cincinnati OH US 45244 45244
FDA Registration Numbers#
- 1524213
- 2023365
- 2022994
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QDZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack | Diasorin Molecular, LLC | 2022-11-05 |