ALPCO Calprotectin Immunoturbidimetric Assay 80-CALPHU-ITCON

GUDID B24280CALPHUITCON0

The Calprotectin Immunoturbidimetric Assay - Controls is an accessory used in conjunction with the Calprotectin Immunoturbidimetric Assay (80-CALPHU-IT200) by trained laboratory personnel.

AMERICAN LABORATORY PRODUCTS COMPANY, LTD.

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• Primary Device ID: B24280CALPHUITCON0
• NIH Device Record Key: 4e13a5d5-10e7-44ac-a6a2-fbdfc49b979d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALPCO Calprotectin Immunoturbidimetric Assay
• Version Model Number: 80-CALPHU-ITCON
• Catalog Number: 80-CALPHU-ITCON
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B24280CALPHUITCON0 [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: 2023-08-28
• Device Publish Date: 2023-08-18

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