Infinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers

GUDID 00845275000016

Fisher Diagnostics

Ammonia IVD, kit, spectrophotometry

• Primary Device ID: 00845275000016
• NIH Device Record Key: 653cd4a1-a23c-4517-927d-edcf95c247c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers
• Version Model Number: OSR61154
• Company DUNS: 183998769
• Company Name: Fisher Diagnostics
• 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: false
• Device Combination Product: false
• Single Use: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845275000016 [Primary]

FDA Product Code

• JIF: Enzymatic Method, Ammonia

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: 2025-11-26
• Device Publish Date: 2025-11-18

Devices Manufactured by Fisher Diagnostics

• 00845275000016 - Infinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers: 2025-11-26
• 00845275000016 - Infinity Ammonia Reagent for Beckman Coulter AU Chemistry Analyzers: 2025-11-26
• 00845275004052 - Thermo Scientific Trutol™: 2019-11-19
• 00845275004069 - Thermo Scientific Trutol™: 2019-11-19
• 00845275004076 - Thermo Scientific Trutol™: 2019-11-19
• 00845275004090 - Thermo Scientific Trutol™: 2019-11-19
• 00845275004106 - Thermo Scientific Trutol™: 2019-11-19
• 00845275004113 - Thermo Scientific Trutol™: 2019-11-19
• 00845275004823 - Thermo Scientific Trutol™: 2019-11-19