Identity
- Trade Name
- ALPCO Lactoferrin CLIA Kit FDA UDI
- Generic Name
- Lactoferrin IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Lactoferrin CLIA Kit is a chemiluminescent immunoassay based on the use of specific antibodies against lactoferrin. The KleeYa system allows for complete automation of immunoassays. The Lactoferrin CLIA Kit is intended for use by trained laboratory personnel for the quantitative measurement of fecal lactoferrin in human stool samples. FDA UDI
- Model / Reference
- 80-LACHU-FC100 FDA UDI
- Description
- The Lactoferrin CLIA Kit is a chemiluminescent immunoassay based on the use of specific antibodies against lactoferrin. The KleeYa system allows for complete automation of immunoassays. The Lactoferrin CLIA Kit is intended for use by trained laboratory personnel for the quantitative measurement of fecal lactoferrin in human stool samples. FDA UDI
Identifiers
- Catalog Number
- 80-LACHU-FC100 FDA UDI
- Primary DI / UDI-DI
- B24280LACHUFC1000 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
Yes
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)
ALPCO Lactoferrin CLIA Kit by American Laboratory Products Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Lactoferrin IVD, kit, enzyme immunoassay (EIA).
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- LACTOFERRIN SCAN — TECHLAB, INC. · Class I
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- Lactoferrin ELISA — IMMUNDIAGNOSTIK, INC. · Class I
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
- American Laboratory Products Company
Sources (1)
- FDA UDI 35569c9e-0d12-4e59-be61-f2f027daa517 36 fields · synced May 30, 2026