BÜHLMANN fCAL® turbo Reagent Kit

GUDID EBUHBKPELARSET0

Bühlmann Laboratories AG

Pancreatic elastase (PE) IVD, reagent Pancreatic elastase (PE) IVD, reagent Pancreatic elastase (PE) IVD, reagent Pancreatic elastase (PE) IVD, reagent Pancreatic elastase (PE) IVD, reagent Pancreatic elastase (PE) IVD, reagent Pancreatic elastase (PE) IVD, reagent Pancreatic elastase (PE) IVD, reagent Pancreatic elastase (PE) IVD, reagent Pancreatic elastase (PE) IVD, reagent Pancreatic elastase (PE) IVD, reagent 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