Identity
- Trade Name
- LACTOFERRIN CHEK FDA UDI
- Generic Name
- Lactoferrin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The LACTOFERRIN CHEK test is an ELISA for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to help identify patients with active inflammatory bowel disease (IBD) and rule out those with active irritable bowel syndrome (IBS), which is noninflammatory. FDA UDI
- Model / Reference
- T5008 FDA UDI
- Description
- The LACTOFERRIN CHEK test is an ELISA for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to help identify patients with active inflammatory bowel disease (IBD) and rule out those with active irritable bowel syndrome (IBS), which is noninflammatory. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857031002271 FDA UDI
- 510(k) Number
- K011396 FDA UDI
- FDA Product Code
- DEG FDA UDI
- GMDN Term
- Lactoferrin IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.5570 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
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
Category: Lactoferrin IVD, kit, enzyme immunoassay (EIA)
Lactoferrin Chek by Techlab, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Lactoferrin IVD, kit, enzyme immunoassay (EIA).
- ALPCO Lactoferrin CLIA Kit — American Laboratory Products Company · Class I
- Lactoferrin ELISA — IMMUNDIAGNOSTIK, INC. · Class I
- Lactoferrin ELISA — IMMUNDIAGNOSTIK, INC. · Class I
- LACTOFERRIN SCAN — TECHLAB, INC. · Class I
- LACTOFERRIN SCAN — TECHLAB, INC. · Class I
- LACTOFERRIN CHEK — TECHLAB, INC. · Class I
Cleared under the same submission
K011396 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 9d05776c-34fb-45a1-b079-36d80e1830d9 34 fields · synced Jun 8, 2026