Product code QKE
- Device name
- Immunoassay, Pregnanediol Glucuronide, Over The Counter
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1620
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Over-the-counter detection of pregnanediol glucuronide for the confirmation of ovulation
- Source
- FDA openFDA device classification dataset