Product code
QKE: Immunoassay, pregnanediol glucuronide, over the counter
FDA product code · Class I · Toxicology
Key facts
| Product code | QKE |
|---|---|
| Device | Immunoassay, pregnanediol glucuronide, over the counter |
| Device class | Class I |
| Regulation number | 862.1620 |
| Review panel | Toxicology |
| Medical specialty | Clinical Chemistry |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1–9 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