Identity
- Trade Name
- LEUKO EZ VUE FDA UDI
- Generic Name
- Lactoferrin IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- The LEUKO EZ VUE® test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE® test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing. FDA UDI
- Model / Reference
- T5019 FDA UDI
- Description
- The LEUKO EZ VUE® test is an immunochromatographic test for the qualitative detection of elevated levels of fecal lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The LEUKO EZ VUE® test detects lactoferrin in liquid, semi-solid, and solid fecal specimens. A positive test result indicates an increased level of fecal lactoferrin and warrants additional testing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857031002530 FDA UDI
- 510(k) Number
- K071712 FDA UDI
- FDA Product Code
- DEG FDA UDI
- GMDN Term
- Lactoferrin IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.5570 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
Yes
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
Leuko Ez Vue by Techlab, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K071712 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 I | Pending data |
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Manufacturer
- Manufacturer
- Techlab, Inc.
Sources (1)
- FDA UDI fbb6b05d-fa8e-4b98-870f-321c26d09cb1 35 fields · synced Jun 6, 2026