Identity
- Trade Name
- EZ Detect Fecal Occult Blood Test FDA UDI
- Generic Name
- Faecal occult blood IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- The EZ DETECT Test is for in vitro qualitative detection of occult blood in the stool -- an early indicator of various gastrointestinal bleeding disorders. The test is dispensed by the physician to the patient for home use. FDA UDI
- Model / Reference
- 1001 FDA UDI
- Description
- The EZ DETECT Test is for in vitro qualitative detection of occult blood in the stool -- an early indicator of various gastrointestinal bleeding disorders. The test is dispensed by the physician to the patient for home use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08305900010015 FDA UDI
- 510(k) Number
- K860028 FDA UDI
- FDA Product Code
- KHE FDA UDI
- GMDN Term
- Faecal occult blood IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.6550 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
EZ Detect Fecal Occult Blood Test by Biomerica, Inc. — 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
- Biomerica, Inc.
Sources (1)
- FDA UDI caf07d6b-c8b8-431b-a27e-c5a5a05f9c11 36 fields · synced May 30, 2026