ALPCO Calprotectin Immunoturbidimetric Assay 80-CALPHU-IT100

GUDID B24280CALPHUIT100

The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for the quantitative measurement of human fecal calprotectin in human stool. The ALPCO Calprotectin Immunoturbidimetric Assay is intended for in-vitro diagnostic use as an aid in diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.

AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry Calprotectin IVD, kit, nephelometry/turbidimetry

• Primary Device ID: B24280CALPHUIT100
• NIH Device Record Key: b4f9956b-1931-49a2-a8ef-d8a39d1c8391
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALPCO Calprotectin Immunoturbidimetric Assay
• Version Model Number: 80-CALPHU-IT100
• Catalog Number: 80-CALPHU-IT100
• Company DUNS: 784143778
• Company Name: AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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	B24280CALPHUIT100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220763

FDA Product Code

• NXO: Calprotectin, Fecal

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: 2023-06-19
• Device Publish Date: 2023-06-09

On-Brand Devices [ALPCO Calprotectin Immunoturbidimetric Assay]

• B24280CALPHUIT100: The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for th
• B24280CALPHUITCON0: The Calprotectin Immunoturbidimetric Assay - Controls is an accessory used in conjunction with t
• B24280CALPHUIT2000: The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay intended for th