FDA product code QDZ: Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
QDZ is the FDA product code for qualitative cytomegalovirus nucleic acid-based detection device for congenital cytomegalovirus infection. It is a Class II device, regulated under 21 CFR 866.3181 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under QDZ, 1 in the last five years. The average 510(k) review took 775 days (median 775). 1 De Novo request was granted under it.
Definition
The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies.
Classification
| Field | Value |
|---|---|
| Device name | Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection |
| Device class | Class II |
| Regulation | 21 CFR 866.3181 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QDZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 775 |
Compare with all 510(k) review times · Search every QDZ clearance
Top QDZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diasorin Molecular, LLC | 1 | 2022-11-05 |
Most recent QDZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202755 | Diasorin Molecular, LLC | Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack | 2022-11-05 | 775 |
Recalls for QDZ devices
openFDA lists no recalls for product code QDZ.
Frequently asked questions
What is FDA product code QDZ?
QDZ is the FDA product code for qualitative cytomegalovirus nucleic acid-based detection device for congenital cytomegalovirus infection. It is a Class II device, regulated under 21 CFR 866.3181 and reviewed by the Microbiology panel.
What device class is QDZ?
Class II, regulation 21 CFR 866.3181. Typical premarket route: 510(k).
How long does a 510(k) take for product code QDZ?
Across 1 cleared submissions the average was 775 days from receipt to decision (median 775).
Which companies have the most QDZ clearances?
Diasorin Molecular, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QDZ
- Run a recall and safety report across every QDZ manufacturer
- Watch product code QDZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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