ProNephro AKI™ (NGAL) Reagent Kit

GUDID 05711435000248

Bioporto Diagnostics A/S

Neutrophil gelatinase-associated lipocalin (NGAL) IVD, reagent

• Primary Device ID: 05711435000248
• NIH Device Record Key: b1270948-4261-409d-8380-578c437239cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProNephro AKI™ (NGAL) Reagent Kit
• Version Model Number: ST101UB
• Company DUNS: 586925158
• Company Name: Bioporto Diagnostics A/S
• 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: true
• 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: +4545290000
• Email: ra@bioporto.com
• Phone: +4545290000
• Email: ra@bioporto.com
• Phone: +4545290000
• Email: ra@bioporto.com
• Phone: +4545290000
• Email: ra@bioporto.com
• Phone: +4545290000
• Email: ra@bioporto.com
• Phone: +4545290000
• Email: ra@bioporto.com
• Phone: +4545290000
• Email: ra@bioporto.com
• Phone: +4545290000
• Email: ra@bioporto.com
• Phone: +4545290000
• Email: ra@bioporto.com
• Phone: +4545290000
• Email: ra@bioporto.com
• Phone: +4545290000
• Email: ra@bioporto.com
• Phone: +4545290000
• Email: ra@bioporto.com
• Phone: +4545290000
• Email: ra@bioporto.com
• Phone: +4545290000
• Email: ra@bioporto.com
• Phone: +4545290000
• Email: ra@bioporto.com
• Phone: +4545290000
• Email: ra@bioporto.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
• 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
GS1	05711435000248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232761

FDA Product Code

• PIG: Acute Kidney Injury Test System

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: 2024-08-12
• Device Publish Date: 2024-08-02

Devices Manufactured by Bioporto Diagnostics A/S

• 05711435000248 - ProNephro AKI™ (NGAL) Reagent Kit: 2024-08-12
• 05711435000248 - ProNephro AKI™ (NGAL) Reagent Kit: 2024-08-12
• 05711435000255 - ProNephro AKI™ (NGAL) Calibrator Kit: 2024-08-12
• 05711435000262 - ProNephro AKI™ (NGAL) Control Kit: 2024-08-12