FDA.reportPublic FDA data

PHOENIX DIAGNOSTICS, INC.

Primary DI
00853366007301
Brand
PHOENIX DIAGNOSTICS, INC.
Company
PHOENIX DIAGNOSTICS, INC.
Model
E-300
Device description
Na+ Electrode for Roche / Hitachi Chemistry Systems
Published
2018-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JGSElectrode, Ion Specific, Sodium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JGSElectrode, Ion Specific, SodiumClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013451000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013451000PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIESPhoenix Diagnostics, Inc.2001-12-18CGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853366007301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853366007301008533660073018533660073010853366007301

GMDN Terms#

Term, Definition table
TermDefinition
Sodium (Na+) electrode IVDAn electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of sodium (Na+) ions in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
606814960
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10852676007121Phoenix Diagnostics1007AM1007AM2023-08-09
10852676007138Phoenix Diagnostics1008AM1008AM2023-08-09
10852676007145Phoenix Diagnostics1009AM1009AM2023-08-09
10852676007152Phoenix Diagnostics1001P1001P2023-08-09
10852676007169Phoenix Diagnostics1002P1002P2023-08-09
10852676007176Phoenix Diagnostics1003P1003P2023-08-09
10852676007183Phoenix Diagnostics1004P1004P2023-08-09
10852676007190Phoenix DiagnosticsPH5001PH50012023-08-09
10852676007206Phoenix DiagnosticsPD500APD500A2023-08-09
10852676007213Phoenix DiagnosticsPD500SPD500S2023-08-09
00852676007063Phoenix Diagnostics3-2243-2242023-08-09
00852676007087Phoenix DiagnosticsPH5041PH50412023-08-09
00852676007094Phoenix DiagnosticsPH5042PH50422023-08-09
00852676007100Phoenix DiagnosticsPH5020PH50202023-08-09
10852676007060Phoenix Diagnostics3-2243-2242023-08-09
00852676007070Phoenix DiagnosticsPH5009PH50092023-08-09
10852676007084Phoenix DiagnosticsPH5041PH50412023-08-09
10852676007091Phoenix DiagnosticsPH5042PH50422023-08-09
10852676007107Phoenix DiagnosticsPH5020PH50202023-08-09
10852676007114Phoenix Diagnostics1006AM1006AM2023-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00380740215712AlinityABBOTT LABORATORIESJGS2025-10-08
00385480574549Stat ProfileNOVA BIOMEDICAL CORPORATIONJGS2022-12-08
00385480574587Stat ProfileNOVA BIOMEDICAL CORPORATIONJGS2022-12-08
00385480596961Stat ProfileNOVA BIOMEDICAL CORPORATIONJGS2022-12-08
00385480616058Stat Profile NOVA BIOMEDICAL CORPORATIONJGS2022-06-16
00385480646048Stat ProfileNOVA BIOMEDICAL CORPORATIONJGS2022-06-06
10054749005519i-STATABBOTT POINT OF CARE INC.JGS2020-05-01
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.JGS2020-04-15
00380740156855ARCHITECTABBOTT LABORATORIESJGS2019-10-31
00380740163372ARCHITECTAbbott GmbHJGS2019-08-15
00386100002282ISE Reagent PackMEDICA CORPORATIONJGS2019-02-14
00386100004378EasyRA Analyzer (LIS)MEDICA CORPORATIONJGS2019-02-14
00386100004385EasyRA Analyzer (ISE&LIS)MEDICA CORPORATIONJGS2019-02-14
00386100002558EasyElectrolyte Reagent Module, Na/K/Li AnalyzersMEDICA CORPORATIONJGS2018-12-11
00386100003524Na/K/Li AnalyzerMEDICA CORPORATIONJGS2018-12-11
00386100002596pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONJGS2018-12-05
00386100002633Bi-Level QC Kit, HCTMEDICA CORPORATIONJGS2018-12-05
00386100002664Reagent ModuleMEDICA CORPORATIONJGS2018-12-05
00386100003630pH/pCO2/pO2/Na/K/Cl AnalyzerMEDICA CORPORATIONJGS2018-12-05
00386100003739pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONJGS2018-12-05
00386100002398Daily Cleaning Solution Kit MEDICA CORPORATIONJGS2018-12-04
00386100002862Na/K AnalyzerMEDICA CORPORATIONJGS2018-12-04
00386100002879Na/K/Cl AnalyzerMEDICA CORPORATIONJGS2018-12-04
00386100002886Lithium Na/K/Li AnalyzerMEDICA CORPORATIONJGS2018-12-04
00386100002893Calcium Na/K/Ca/pH AnalyzerMEDICA CORPORATIONJGS2018-12-04
00386100002909Na/K/Cl/Li AnalyzerMEDICA CORPORATIONJGS2018-12-04
00386100002916Na/K/Cl/Li Solution Pack MEDICA CORPORATIONJGS2018-12-04
00386100002923Na/K/Cl/Li Solution PackMEDICA CORPORATIONJGS2018-12-04
00386100002985Reference ElectrodeMEDICA CORPORATIONJGS2018-12-04
00386100003029Na/K Solution PackMEDICA CORPORATIONJGS2018-12-04