ProNephro AKI™ (NGAL) Reagent Kit

Basic Information

• Brand Name: ProNephro AKI™ (NGAL) Reagent Kit
• Primary DI: 05711435000248
• Version / Model: ST101UB
• Company Name: Bioporto Diagnostics A/S
• Labeler DUNS: 586925158
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-02
• Public Version: 2
• Public Version Date: 2025-02-13
• Public Version Status: Update
• Public Device Record Key: b1270948-4261-409d-8380-578c437239cd
• Distribution End Date: 2025-02-12

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PIG	Acute Kidney Injury Test System	Clinical Chemistry	862.1220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47430	Neutrophil gelatinase-associated lipocalin (NGAL) IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of neutrophil gelatinase-associated lipocalin (NGAL) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05711435000248	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K232761	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius