Identity
- Trade Name
- Clearblue Pregnancy Test Combo pack FDA UDI
- Generic Name
- Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- A convenience kit consisting of 1 Clearblue Digital Pregnancy Test with Weeks Estimator device and 1 Clearblue Plus Pregnancy Test device. FDA UDI
- Model / Reference
- CB9a / CB11 FDA UDI
- Description
- A convenience kit consisting of 1 Clearblue Digital Pregnancy Test with Weeks Estimator device and 1 Clearblue Plus Pregnancy Test device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00633472600265 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
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
No
FDA UDI
Clearblue Pregnancy Test Combo pack by Spd Swiss Precision Diagnostics Gmbh — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Spd Swiss Precision Diagnostics Gmbh
Sources (1)
- FDA UDI cf23367c-40d2-4e9c-ae14-defb1dee18a1 36 fields · synced Jun 8, 2026