BÜHLMANN fPELA® turbo Control Kit

GUDID EBUHBKPELACONSET0

Bühlmann Laboratories AG

Pancreatic elastase (PE) IVD, control

• Primary Device ID: EBUHBKPELACONSET0
• NIH Device Record Key: 80442965-11ed-45e7-becb-d60d8cfc3048
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BÜHLMANN fPELA® turbo Control Kit
• Version Model Number: B-KPELA-CONSET
• 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	EBUHBKPELACONSET0 [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

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• 07613336169926 - fCAL turbo: 2022-06-10
• EBUH089104991900 - fCAL Calibrator Set: 2022-06-10
• EBUH089109870010 - CALEX Cap: 2021-07-22
• EBUHBIPOCTRABS0 - Quantum Blue® Reader: 2021-01-20
• EBUHBKPELACONSET0 - BÜHLMANN fPELA® turbo Control Kit: 2020-06-30
• EBUHBKPELACONSET0 - BÜHLMANN fPELA® turbo Control Kit: 2020-06-30