Identity
- Trade Name
- Rapid Response FDA UDI
- Generic Name
- Faecal occult blood IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Rapid Response Fecal Immunochemical Test - 36 tests/ kit are for the qualitative detection of human hemoglobin in feces. FDA UDI
- Model / Reference
- FOB-9C36 FDA UDI
- Description
- Rapid Response Fecal Immunochemical Test - 36 tests/ kit are for the qualitative detection of human hemoglobin in feces. FDA UDI
Identifiers
- Catalog Number
- FOB-9C36 FDA UDI
- Primary DI / UDI-DI
- 00722066001882 FDA UDI
- FDA Product Code
- KHE FDA UDI
- GMDN Term
- Faecal occult blood IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.6550 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
Yes
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
Category: Faecal occult blood IVD, kit, rapid ICT, clinical
Rapid Response by BTNX Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K110309 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
- BTNX Inc
Sources (1)
- FDA UDI a8415781-8d4f-4206-9c22-215a6015bd3b 35 fields · synced Jun 6, 2026