Product code
QDZ: Qualitative cytomegalovirus nucleic acid-based detection device for congenital cytomegalovirus infection
FDA product code · Class II · Microbiology
Key facts
| Product code | QDZ |
|---|---|
| Device | Qualitative cytomegalovirus nucleic acid-based detection device for congenital cytomegalovirus infection |
| Device class | Class II |
| Regulation number | 866.3181 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | The device is a qualitative, in vitro diagnostic test for the direct detection of Cytomegalovirus (CMV) DNA in saliva from newborn babies. |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database