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EZ Detect Colon Disease Test
EUDAMEDFDA UDIClass IVD devices for self-testing (EU MDR)
Ref 1000-1
Identity
- Trade Name
- EZ Detect Colon Disease Test EUDAMEDFDA UDI
- Generic Name
- Faecal occult blood IVD, kit, rapid colorimetric, clinical FDA UDI
- Device Name
- EZ Detect Colon Disease Test EUDAMEDHome Test For Hidden Blood in The Stool FDA UDI
- Model / Reference
- 1000-1 EUDAMEDFDA UDI
- Description
- Home Test For Hidden Blood in The Stool FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00083059100013 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00083059100013 EUDAMED
- 510(k) Number
- K860028 FDA UDI
- FDA Product Code
- KHE FDA UDI
- EMDN Code
- W0102039013 FECAL OCCULT BLOOD (IC) EUDAMED
- GMDN Term
- Faecal occult blood IVD, kit, rapid colorimetric, clinical FDA UDI
Classification
- Device Class
- Class IVD devices for self-testing EUDAMEDClass II FDA UDI
- Regulation Number
- 864.6550 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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
EZ Detect Colon Disease Test by Biomerica, Inc. — Class IVD devices for self-testing — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00083059100013 | Class IVD devices for self-testing | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD devices for self-testing | Pending data |
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Manufacturer
- Manufacturer
- Biomerica, Inc.
- EUDAMED SRN
- US-MF-000015772
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED f0afdf2f-a176-48fe-9eee-fb9bdbf00e2f 61 fields · synced Aug 4, 2026
- FDA UDI ec47ca5f-6b24-4efb-931c-abe2886639fa 35 fields · synced May 29, 2026