Identity
- Trade Name
- LACTOFERRIN SCAN FDA UDI
- Generic Name
- Lactoferrin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The LACTOFERRIN SCAN® test is a quantitative ELISA for measuring concentrations of fecal lactoferrin, a marker for fecal leukocytes. An elevated level is an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to distinguish patients with active inflammatory bowel disease (IBD) from those with noninflammatory irritable bowel syndrome (IBS). FDA UDI
- Model / Reference
- T5009 FDA UDI
- Description
- The LACTOFERRIN SCAN® test is a quantitative ELISA for measuring concentrations of fecal lactoferrin, a marker for fecal leukocytes. An elevated level is an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to distinguish patients with active inflammatory bowel disease (IBD) from those with noninflammatory irritable bowel syndrome (IBS). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857031002288 FDA UDI
- 510(k) Number
- K042071 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 Scan 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 CHEK — TECHLAB, INC. · Class I
- LACTOFERRIN SCAN — TECHLAB, INC. · Class I
- LACTOFERRIN CHEK — TECHLAB, INC. · Class I
Cleared under the same submission
K042071 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Techlab, Inc.
Sources (1)
- FDA UDI fe186048-360e-4404-867c-11eee52328fd 34 fields · synced May 31, 2026