ALPCO Calprotectin Chemiluminescence ELISA 80-CALPHU-CH01

GUDID B24280CALPHUCH010

The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemiluminescent assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The ALPCO Calprotectin Chemiluminescence ELISA is intended for in vitro diagnostic use as an aid in the 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, chemiluminescent immunoassay

• Primary Device ID: B24280CALPHUCH010
• NIH Device Record Key: 03b22774-8dca-4a29-ac1e-a8ce50e3799b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALPCO Calprotectin Chemiluminescence ELISA
• Version Model Number: 80-CALPHU-CH01
• Catalog Number: 80-CALPHU-CH01
• 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

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	B24280CALPHUCH010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191807

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: 2019-11-07
• Device Publish Date: 2019-10-30

On-Brand Devices [ALPCO Calprotectin Chemiluminescence ELISA]

• B24280CALPHUCH010: The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemiluminescent assay
• B24280CALPHUCH500: The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemiluminescent assay