Identity
- Trade Name
- Clearblue FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Clearblue 6 Day Visual Pregnancy 2ct US (CB17) FDA UDI
- Model / Reference
- Early Detection Pregnancy Test FDA UDI
- Description
- Clearblue 6 Day Visual Pregnancy 2ct US (CB17) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00633472601934 FDA UDI
- 510(k) Number
- K172257 FDA UDI
- FDA Product Code
- LCX FDA UDI
- GMDN Term
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1155 FDA UDI
- Commercial Distribution
- Not 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
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
Clearblue by Procter & Gamble Manufacturing Company, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Procter & Gamble Manufacturing Company, The
Sources (1)
- FDA UDI e0ee44fb-a038-4e66-8774-8e072b1cf381 37 fields · synced Jun 1, 2026