Infinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers

Basic Information

• Brand Name: Infinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers
• Primary DI: 00845275000016
• Version / Model: OSR61154
• Company Name: Fisher Diagnostics
• Labeler DUNS: 183998769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-18
• Public Version: 1
• Public Version Date: 2025-11-26
• Public Version Status: New
• Public Device Record Key: 653cd4a1-a23c-4517-927d-edcf95c247c1

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• 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
JIF	Enzymatic Method, Ammonia	Clinical Chemistry	862.1065	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53205	Ammonia IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of ammonia in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845275000016	GS1