Panels › Microbiology › Product code QDZ · Class 2
Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
Regulation 866.3181
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QDZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Diasorin Molecular, LLC | 1 | 0 |
| Meridian Bioscience, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 5, 2022 | K202755 | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack Diasorin Molecular, LLC | QDZ |
| Nov 30, 2018 | DEN180040 | Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit Meridian Bioscience, Inc. | QDZ |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.