ALPCO Lactoferrin CLIA Kit 80-LACHU-FC100

GUDID B24280LACHUFC1000

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.

AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Lactoferrin IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B24280LACHUFC1000
• NIH Device Record Key: 35569c9e-0d12-4e59-be61-f2f027daa517
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALPCO Lactoferrin CLIA Kit
• Version Model Number: 80-LACHU-FC100
• Catalog Number: 80-LACHU-FC100
• Company DUNS: 784143778
• Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.com
• Phone: 800.592.5726
• Email: cs@alpco.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B24280LACHUFC1000 [Primary]

FDA Product Code

• DEG: Lactoferrin, Antigen, Antiserum, Control

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-11
• Device Publish Date: 2025-03-03

Devices Manufactured by AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

• B24280LACHUFC1000 - ALPCO Lactoferrin CLIA Kit: 2025-03-11The 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.
• B24280LACHUFC1000 - ALPCO Lactoferrin CLIA Kit: 2025-03-11 The Lactoferrin CLIA Kit is a chemiluminescent immunoassay based on the use of specific antibodies against lactoferrin. The Klee
• B24211HGHHUE010 - Human Growth Hormone ELISA: 2025-01-28 The Glucagon ELISA is for the quantitative measurement of Growth Hormone (GH) in human serum by an ELISA (Enzyme-Linked Immunoso
• B24211GLUHUE010 - Glucagon ELISA: 2024-10-31 The Glucagon ELISA is a quantitative Enzyme-Linked Immunosorbent Assay for the determination of Glucagon in human EDTA plasma sa
• B24280PANHUFC1000 - ALPCO Pancreatic Elastase CLIA: 2024-08-02 The Pancreatic Elastase CLIA kit is a chemiluminescent immunoassay (CLIA) intended for use by trained laboratory personnel for t
• B24220TT3HUE011 - Total Triiodothyronine (Total T3) ELISA: 2024-07-30 The Total Triiodothyronine (Total T3) ELISA Kit is intended for the quantitative determination of total triiodothyronine (T3) co
• B24280CALPHUIT2000 - ALPCO Calprotectin Immunoturbidimetric Assay: 2023-08-28 The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for the quantitative measurement of hu
• B24280CALPHUITCAL0 - Calprotectin Immunoturbidimetric Assay - Calibrators: 2023-08-28 The Calprotectin Immunoturbidimetric Assay - Calibrators is an accessory used in conjunction with the Calprotectin Immunoturbidi
• B24280CALPHUITCON0 - ALPCO Calprotectin Immunoturbidimetric Assay: 2023-08-28 The Calprotectin Immunoturbidimetric Assay - Controls is an accessory used in conjunction with the Calprotectin Immunoturbidimet