PHOENIX DIAGNOSTICS, INC.

GUDID 00853366007349

Reference Electrode Cartridge for Roche / Hitachi Chemistry Systems

PHOENIX DIAGNOSTICS, INC.

Reference electrode IVD
Primary Device ID00853366007349
NIH Device Record Keya72b99f4-c115-445e-b616-210f3c500d71
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHOENIX DIAGNOSTICS, INC.
Version Model NumberE-340
Company DUNS606814960
Company NamePHOENIX DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853366007349 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJPElectrode, Ion Selective (Non-Specified)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-30
Device Publish Date2018-01-26

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00853366007714Rinse Solution for I.L. 943
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00853366007691Flame Standard 140/5 for I.L. 943
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00853366007271ISE Compensator for Roche / Hitachi Chemistry Systems
00853366007264System Cleaning Solution for Roche / Hitachi Chemistry Systems
10853366007254Cell Clean 90, 1N NaOH for Roche / Hitachi Chemistry Systems
10853366007230Hitergent for Roche / Hitachi 700 Series
10853366007209ISE 1N KCL Sol for Roche / Hitachi 911 Series Chemistry Systems
00853366007189ISE Internal Ref Sol for Roche / Hitachi 911 Series Chemistry Systems
00853366007165ISE Diluent for Roche / Hitachi 911 Series Chemistry Systems
00853366007158ISE Diluent for Roche / Hitachi 700 & 900 Series Chemistry Systems
00853366007134Reference Electrode for Olympus AU Series Chemistry Systems
00853366007127Cl- Electrode for Olympus AU Series Chemistry Systems
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00853366007103Na+ Electrode for Olympus AU Series Chemistry Systems
10853366007094Cleaning Solution for Olympus AU Series Chemistry Systems
10853366007087ISE Na+ and K+ Selectivity Check Solutions for Olympus AU Series Chemistry Systems
10853366007070ISE Internal Reference Fill Solution for Olympus AU Series Chemistry Systems
10853366007063ISE Low/High Urine Standard for Olympus AU Series Chemistry Systems
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