Alpco Lactoferrin Clia Kit

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…

Registry build 21.09.26

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.

1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Hunan.

Chinese manufacturers registered for FDA product code DEG
Manufacturer City Province Registered as Device types
AVE Science & Technology Co., Ltd. Changsha Hunan Manufacturer 22

Record

Regulatory record for Alpco Lactoferrin Clia Kit
Listed by American Laboratory Products Company, United States
FDA product code DEG
Device type Lactoferrin, Antigen, Antiserum, Control
Device class Class 1
Regulation 21 CFR 866.5570
Establishment Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2025-03-03

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Alpco Lactoferrin Clia Kit
Catalogue number Size Status
80-LACHU-FC100 In distribution
80-LACHU-FC900 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Anti-Lactoferrin Elisa DRG Instruments Gesellschaft mit beschränkter Haftung 2
Lactoferrin Chek Techlab, Inc. 2
Leuko EZ VUE Techlab, Inc. 2
Lactoferrin EZ VUE Techlab, Inc. 2
Lactoferrin Scan Techlab, Inc. 2
Lactoferrin Elisa Immundiagnostik, Inc. 2
Lactoferrin Clia Re-Calibrator and Control Set American Laboratory Products Company 1
GeroaDX Geroa Diagnostics Sociedad Limitada 1
QuickVue TLI Lactoferrin Test Techlab, Inc. 1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer