BÜHLMANN fCAL® turbo Reagent Kit

GUDID EBUHBKPELARSET0

Bühlmann Laboratories AG

Pancreatic elastase (PE) IVD, reagent

• Primary Device ID: EBUHBKPELARSET0
• NIH Device Record Key: 225528f2-54f3-4fd0-ba7e-ac6a247921da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BÜHLMANN fCAL® turbo Reagent Kit
• Version Model Number: B-KCAL-RSET
• Company DUNS: 481261006
• Company Name: Bühlmann Laboratories AG
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBUHBKPELARSET0 [Primary]

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: 2020-06-30
• Device Publish Date: 2020-06-22

On-Brand Devices [BÜHLMANN fCAL® turbo Reagent Kit]

• EBUHBKCALRSET0: Reagent kit for quantitative PETIA assay for the determination of calprotectin (MRP8/14) in huma
• EBUHBKPELARSET0: B-KCAL-RSET
• EBUHBKCALRSETUS0: B-KCAL-RSET-US