Identity
- Trade Name
- Frida FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing FDA UDI
- Device Name
- Early Detection Pregnancy Tests FDA UDI
- Model / Reference
- 500001287 FDA UDI
- Description
- Early Detection Pregnancy Tests FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10810028774084 FDA UDI
- 510(k) Number
- K172257 FDA UDI
- FDA Product Code
- LCX FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 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
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Category: Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing
Frida by Fridababy, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K172257 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fridababy, LLC
Sources (1)
- FDA UDI 9be13beb-22cc-4166-9923-8a54915300d2 34 fields · synced Jun 1, 2026