BÜHLMANN fCAL® ELISA

GUDID EBUHBEKCAL0

Quantitative ELISA assay for the determination of calprotectin (MRP8/14) in human stool specimens

Bühlmann Laboratories AG

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• Primary Device ID: EBUHBEKCAL0
• NIH Device Record Key: 35529fec-8c64-4ddd-9b7f-182784fdd321
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BÜHLMANN fCAL® ELISA
• Version Model Number: EK-CAL
• Company DUNS: 481261006
• Company Name: Bühlmann Laboratories AG
• 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: false
• 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: (844) 300-9799
• Email: info@buhlmannlabs.com
• Phone: (844) 300-9799
• Email: info@buhlmannlabs.com
• Phone: (844) 300-9799
• Email: info@buhlmannlabs.com
• Phone: (844) 300-9799
• Email: info@buhlmannlabs.com
• Phone: (844) 300-9799
• Email: info@buhlmannlabs.com
• Phone: (844) 300-9799
• Email: info@buhlmannlabs.com
• Phone: (844) 300-9799
• Email: info@buhlmannlabs.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	EBUHBEKCAL0 [Primary]

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: 2019-11-14
• Device Publish Date: 2019-11-06

On-Brand Devices [BÜHLMANN fCAL® ELISA]

• EBUHBEKCAL20: Quantitative ELISA assay for the determination of calprotectin (MRP8/14) in human stool specimen
• EBUHBEKCAL0: Quantitative ELISA assay for the determination of calprotectin (MRP8/14) in human stool specimen