PHOENIX DIAGNOSTICS, INC.

GUDID 00853366007158

ISE Diluent for Roche / Hitachi 700 & 900 Series Chemistry Systems

PHOENIX DIAGNOSTICS, INC.

Buffered sample diluent IVD, automated/semi-automated system

• Primary Device ID: 00853366007158
• NIH Device Record Key: 12b2eb0a-9b04-4015-9dfd-22b967fe9142
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHOENIX DIAGNOSTICS, INC.
• Version Model Number: 16-201
• Company DUNS: 606814960
• Company Name: PHOENIX DIAGNOSTICS, INC.
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853366007158 [Primary]
GS1	10853366007155 [Package]; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013451

FDA Product Code

• PPM: General Purpose Reagent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-30
• Device Publish Date: 2018-01-26

On-Brand Devices [PHOENIX DIAGNOSTICS, INC.]

• 00853366007783: Calibrator 2 for Tokyo Boeki BiOLiS 50i Series Electrolyte Systems
• 00853366007776: Cal Pack (Snap Pack) for Medica EasyLyte Expand Electrolyte Systems
• 00853366007769: Acid Wash for Tokyo Boeki BiOLiS 50i Series Electrolyte Systems
• 00853366007752: Alkaline Wash for Tokyo Boeki BiOLiS 50i Series Electrolyte Systems
• 10853366007742: Wash Solution for Olympus AU Series Chemistry Systems
• 00853366007721: Urine Standard for I.L. 943
• 00853366007714: Rinse Solution for I.L. 943
• 00853366007707: Cesium Internal Standard for I.L. 943
• 00853366007691: Flame Standard 140/5 for I.L. 943
• 00853366007585: ISE Cal Pack (Snap Pack) for Medica Na/K/Ca/pH EasyLyte Electrolyte Systems
• 00853366007578: Universal Cal Pack (Open) for Medica EasyLyte Series Electrolyte Systems
• 00853366007561: Cleaning Solution
• 00853366007554: Na Conditioning Solution
• 00853366007455: PHOENIX DIAGNOSTICS, INC.
• 00853366007448: Multi-Analyte Chemistry Calibrator (1-Point)
• 00853366007356: ISE Wash for Tokyo Boeki BiOLiS Series Chemistry Systems
• 00853366007349: Reference Electrode Cartridge for Roche / Hitachi Chemistry Systems
• 00853366007332: Reference Electrode for Roche / Hitachi Chemistry Systems
• 00853366007325: Cl- Electrode for Roche / Hitachi Chemistry Systems
• 00853366007318: K+ Electrode for Roche / Hitachi Chemistry Systems
• 00853366007301: Na+ Electrode for Roche / Hitachi Chemistry Systems
• 00853366007271: ISE Compensator for Roche / Hitachi Chemistry Systems
• 00853366007264: System Cleaning Solution for Roche / Hitachi Chemistry Systems
• 10853366007254: Cell Clean 90, 1N NaOH for Roche / Hitachi Chemistry Systems
• 10853366007230: Hitergent for Roche / Hitachi 700 Series
• 10853366007209: ISE 1N KCL Sol for Roche / Hitachi 911 Series Chemistry Systems
• 00853366007189: ISE Internal Ref Sol for Roche / Hitachi 911 Series Chemistry Systems
• 00853366007165: ISE Diluent for Roche / Hitachi 911 Series Chemistry Systems
• 00853366007158: ISE Diluent for Roche / Hitachi 700 & 900 Series Chemistry Systems
• 00853366007134: Reference Electrode for Olympus AU Series Chemistry Systems
• 00853366007127: Cl- Electrode for Olympus AU Series Chemistry Systems
• 00853366007110: K+ Electrode for Olympus AU Series Chemistry Systems
• 00853366007103: Na+ Electrode for Olympus AU Series Chemistry Systems
• 10853366007094: Cleaning Solution for Olympus AU Series Chemistry Systems
• 10853366007087: ISE Na+ and K+ Selectivity Check Solutions for Olympus AU Series Chemistry Systems
• 10853366007070: ISE Internal Reference Fill Solution for Olympus AU Series Chemistry Systems
• 10853366007063: ISE Low/High Urine Standard for Olympus AU Series Chemistry Systems
• 10853366007032: ISE Reference Solution for Olympus AU Series Chemistry Systems
• 00852676009760: Calibrator 1 for NuLyte Systems
• 00852676009753: Calibrator 2 for NuLyte Systems
• 00085336600759: Universal Cal Pack (Snap Pack) for I.L. ILyte Series Electrolyte Systems