Data / Medical devices / Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection (QDZ): 3 FDA-registered makers in 1 country
3 establishments in 1 country are registered with the FDA to make Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection (product code QDZ, Class 2, 21 CFR 866.3181). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on November 5, 2022, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QDZ
- Device class
- 2
- Regulation
- 866.3181
- Medical specialty
- Microbiology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
Makers of Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| DiaSorin Molecular LLC | Cypress, CA, United States | Manufacturer | 1 | November 5, 2022 | 0 | 0 | 0 | api.fda.gov |
| Meridian Bioscience, Inc. | Cincinnati, OH, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | November 30, 2018 | 0 | 0 | 0 | api.fda.gov |
| Planet Innovation Products, Inc. | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 5, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.