Identity
- Trade Name
- Proov FDA UDI
- Generic Name
- Natural conception assistance kit FDA UDI
- Device Name
- Proov PdG, Progesterone Metabolite Test. The only FDA-Cleared Test to Confirm Successful Ovulation at Home. FDA UDI
- Model / Reference
- Confirm FDA UDI
- Description
- Proov PdG, Progesterone Metabolite Test. The only FDA-Cleared Test to Confirm Successful Ovulation at Home. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860002790817 FDA UDI
- 510(k) Number
- K191462 FDA UDI
- FDA Product Code
- QKE FDA UDI
- GMDN Term
- Natural conception assistance kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Natural conception assistance kit
Proov by Mfb Fertility, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mfb Fertility, Inc.
Sources (1)
- FDA UDI 9a556f73-b1a7-400f-8715-3f3529ccb1e4 34 fields · synced May 31, 2026