Electrode, Ion Specific, Sodium

Who Makes This Device Type in China?

2 manufacturers in China hold an FDA registration for this device type, based in Guangdong.

Edan Instruments, Inc. Guangdong, contract manufacturer
Shenzhen Mindray BIO-Medical Electronics Co., Ltd. Guangdong

How Is JGS Classified?

Electrode, Ion Specific, Sodium is FDA product code JGS, Class 2, 21 CFR 862.1665.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 2 clearances under this code; the FDA took a median of 296 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 48 recalls under this product code since 2002. None was by a company in China. The root causes the FDA records most often are Software design (10), Packaging change control (6) and Nonconforming Material/Component (4).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Electrode, Ion Specific, Sodium

Alfa Wassermann

Electrode, Sodium

Electrode, Ion Specific, Sodium

Accessory Kit of ISE

Catalogue number 115-041670-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

RAPIDChem® 700, RAPIDPoint® 340 Trouble Shooting Kit

Trouble shooting kit for use with RAPIDChem® 700, RAPIDPoint® 340 systems.

Electrode, Ion Specific, Sodium

Ready Sensor™ Gold Reference Sensor

Ready Sensor™ Reference Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments

Electrode, Ion Specific, Sodium

RAPIDChem® 700 RAPIDPoint® 350 Sodium Sensor

RAPIDChem® 700 RAPIDPoint® 350 Na+ Sensor, for in vitro diagnostics use with Rapidchem® 700, Rapidpoint® 350 systems.

Electrode, Ion Specific, Sodium

Roche 9180 ISE SnapPak

Catalogue number 3112349180, listed by Roche Diagnostics Gmbh, Germany, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Carolina Liquid Chemistries Corp. ISE Internal Standard Solution DT88820

Catalogue number DT88820, listed by Carolina Liquid Chemistries, United States, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

BS-200 Maintenance Kit

Catalogue number BA20-30-75345, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Sodium Electrode

Catalogue number 781611377, listed by Jeol Ltd., Japan, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Vitros

VITROS Chemistry Products Na+ Slides

Electrode, Ion Specific, Sodium

ISE Sodium Electrode

Ion-Selective Electrode for the measurement of sodium in serum.

Electrode, Ion Specific, Sodium

Electrode for ABL Analyzers

E755 Na electrode for ABL7XX/8XX

Electrode, Ion Specific, Sodium

Selectra

Selectra: 1 catalogue number listed by ELITechGroup B.V., under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Rapidpoint® 340 Reagent Module

RAPIDPOINT® 340 Reagent Module, pH / pCO2 / pO2, for use with Rapidpoint 340 analyzers

Electrode, Ion Specific, Sodium

RAPIDLab® 348 Wash

RAPIDLab® 348/348EX Wash Reagent for in vitro diagnostics use with the RAPIDLab® 348/348EX analyzers.

Electrode, Ion Specific, Sodium

Na/K/Cl Analyzer

EasyElectrolyte Na/K/Cl Analyzer

Electrode, Ion Specific, Sodium

ISE Cleaning Solution Kit

ISE Cleaning Solution Kit for use with EasyElectrolyte Analyzers

Electrode, Ion Specific, Sodium

ISE Reagent Pack

ISE Reagent Pack for use with EasyElectrolyte Analyzers

Electrode, Ion Specific, Sodium

ISE Reagent Module

ISE Reagent Module for use with EasyElectrolyte Analyzers

Electrode, Ion Specific, Sodium

Solution Valve

Catalogue number ME-2108D, listed by Diamond Diagnostics Inc., Hungary, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

BS-800M Chemistry Analyzer

Catalogue number BS-800M, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

REF 905-917 ABL90 Flex sBOX

Solution box for the ABL90 FLEX, SBOX

Electrode, Ion Specific, Sodium

I.S.E. NA

2 catalogue numbers from D200-0014, listed by Randox Laboratories Limited, United Kingdom, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

RAPIDChem® 700 Lithium Sensor

RAPIDChem® 700 Lithium Sensor for in vitro diagnostics use with the Rapidchem ® 700 systems

Electrode, Ion Specific, Sodium

H3 Cartridge

H3 Cartridge, 25 count

Electrode, Ion Specific, Sodium

ISE Sodium Electrode

Catalogue number 4838084001, listed by Roche Diagnostics Gmbh, Germany, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Lamp(12V,20W)

Catalogue number 801-BA80-00222-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Carolina Liquid Chemistries Corp. ISE Reference Solution DT88811

Catalogue number DT88811, listed by Carolina Liquid Chemistries, United States, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Auto Chemistry Analyzer BA-800M

Catalogue number BA-800M, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

NA Electrode, ISE Module

Clinical Chemistry Test Systems / Sodium test system. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used…

Electrode, Ion Specific, Sodium

ProLyte Electrolyte Analyzer

The Prolyte® Electrolyte Analyzer is intended to measure sodium, potassium, chloride and lithium in whole blood, serum, plasma, and urine. Measurements obtained by this device are used to…

Electrode, Ion Specific, Sodium

Sensor Module Cl-

Cl- Sensor module an in vitro diagnostics device to be used on the RAPIDChem® 744 analyzer

Electrode, Ion Specific, Sodium

RAPIDLab® 348/348EX HCT Slope

RAPIDLab® 348/348EX HCT Slope for in vitro diagnostics use with the RAPIDLab® 348/348EX analyzers.

Electrode, Ion Specific, Sodium

EasyElectrolyte Reagent Module, Na/K/Cl Analyzers

EasyElectrolyte Reagent Module for Na/K/Cl Analyzers

Electrode, Ion Specific, Sodium

Auto Chemistry Analyzer BS-200

Catalogue number BS-200, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

RAPIDChem® 744

The Rapidchem® 744 analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), and Cl- (chloride) or Lithium (Li+) in serum,…

Electrode, Ion Specific, Sodium

RAPIDChem® 744 Na+K+Cl- Reagent Module

RAPIDChem® 744 Na+K+Cl- Reagent Module for in vitro diagnostics use with the Rapidchem® 744 system.

Electrode, Ion Specific, Sodium

Roche 9180 Sodium Electrode

Catalogue number 03110419180, listed by Roche Diagnostics Gmbh, Germany, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

ISE Disposable Reference Electrode

ISE Disposable Reference Electrode for use with EasyElectrolyte Analyzers

Electrode, Ion Specific, Sodium

Pointe Scientific

ISE Standard - Low For the standardization of Sodium, Potassium and Chloride on Ion Selective Electrodes. packaged at 10 x 2ml

Electrode, Ion Specific, Sodium

Nova

NOVA 1/1+ Analyzer w/ Printer (No Acc Pack)

Electrode, Ion Specific, Sodium

ABS800 Chemistry Analyzer

Catalogue number ABS800, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Sodium Electrode

Measuring concentration of Sodium in whole blood, serum, plasma, and diluted urine samples.

Electrode, Ion Specific, Sodium

Calibrator Rack Assembly

Catalogue number 801-BA80-00255-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Auto Chemistry Analyzer BS-490

Catalogue number BS-490, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Synermed®

Hitachi ISE Internal Reference 6 X 1000 mL

Electrode, Ion Specific, Sodium

ABX Pentra Sodium-E

Catalogue number 3014029448, listed by Horiba ABX SAS, France, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

RAPIDChem® 700 Urine Diluent

RAPIDChem® 700 Urine Diluent for in vitro use with Rapidchem® 700 systems. Contains: buffers & presevatives

Electrode, Ion Specific, Sodium

RAPIDChem® 754 Na+K+Li+ Reagent Module

RAPIDChem® 754 Na+ K+ Li+ Reagent Module, for in vitro diagnostics use with the Rapidchem® 754 systems.

Electrode, Ion Specific, Sodium

Rapidpoint® 340/350 Po2 Electrode

RAPIDPOINT® 340/350 pO2 Electrode for use with Rapidpoint® 340/350 Analyzers.

Electrode, Ion Specific, Sodium

Stat Profile

Stat Profile pHOx Ultra/CCX Sensor Multi blank

Electrode, Ion Specific, Sodium

RAPIDLab® Conditioner

RAPIDLab® Conditioner kit. An in vitro diagnostic medical device for use with RAPIDLab® series analyzers

Electrode, Ion Specific, Sodium

Manual Rerun Rack Assembly

Catalogue number 801-BA80-00257-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Advia® Chemistry Electrode NA

Sodium - ADVIA Chem. - RGT - 1 Piece

Electrode, Ion Specific, Sodium

Architect

ICT Cleaning Fluid

Electrode, Ion Specific, Sodium

Rapidpoint® 350 Sensor Module

RAPIDPOINT® 350 Sensor Module, an in vitro diagnostics device to be used on the RAPIDPOINT® 350 analyzer

Electrode, Ion Specific, Sodium

Selectra

Selectra: 2 catalogue numbers listed by VitalScientific B.V., Netherlands, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

SelectaLyte (Sodium Electrode)

Catalogue number 3910, listed by Awareness Technology, Inc., United States, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Pointe Scientific, Inc. ISE Internal Reference

For the quantitative determination of sodium, potassium, and chloride in serum. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the…

Electrode, Ion Specific, Sodium

GL Cartridge

GL Cartridge, 25 count

Electrode, Ion Specific, Sodium

Drainage Unit

Catalogue number 115-022518-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Roche 9180 Snappak 9180/9181 Dialysate Type

Catalogue number 3112357182, listed by Roche Diagnostics Gmbh, Germany, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Membrane for E755 Electrode

D755 Na membrane box (4 units) for ABL7XX/8XX

Electrode, Ion Specific, Sodium

BS-480 Common Maintenance Kit(FDA)

Catalogue number 115-028324-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Ready Sensor™ Gold Hct Sensor

Ready Sensor™ Hct Biosensor for in vitro use on the RapidLab® 348/348ex pH/Blood Gas Analyzers.

Electrode, Ion Specific, Sodium

CLC6410 Chemistry Analyzer With or Without ISE

CLC6410 Clinical Chemistry Analyzer with ISE

Electrode, Ion Specific, Sodium

I.S.E. REF

Catalogue number D200-0017, listed by Randox Laboratories Limited, United Kingdom, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Stat Sample Rack Assembly

Catalogue number 801-BA80-00256-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Phoenix Diagnostics, Inc.

ISE Na+ and K+ Selectivity Check Solutions for Olympus AU Series Chemistry Systems

Electrode, Ion Specific, Sodium

Auto Chemistry Analyzer BS-480

Catalogue number BS-480, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

H4 Cartridge

H4 Cartridge, 25 count

Electrode, Ion Specific, Sodium

Na Electrode,indirect,international

Catalogue number 040-000540-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Pointe Scientific, Inc.

ISE Internal Reference, for the quantitative determination of sodium, potassium, and chloride in serum. Sodium measurements are used in the diagnosis and treatment of aldosteronism…

Electrode, Ion Specific, Sodium

Ref Electrode,indirect,international

Catalogue number 040-000539-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Sodium Electrode

Sodium electrode for use with EasyStat and EasyElectrolyte Analyzers

Electrode, Ion Specific, Sodium

Sodium Electrode

ISE electrode for the measure of Sodium in IVD samples.

Electrode, Ion Specific, Sodium

i-STAT

I-Stat Alinity Instrument (Model 500)

Electrode, Ion Specific, Sodium

Sodium Electrode

4 catalogue numbers from 03111598180, listed by Roche Diagnostics Gmbh, Germany, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Na (Sodium) Electrode

Catalogue number 20-27-0474, listed by Tokyo Boeki Medisys, Inc., United States, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Normal Sample Rack Assembly

Catalogue number 801-BA80-00253-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2

GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct, Lac, pH, pCO2 300 test PAK

Electrode, Ion Specific, Sodium

Phoenix Diagnostics

ISE Diluent for Roche / Hitachi 704, 902, and P800 Series Chemistry Systems

Electrode, Ion Specific, Sodium

AU

ISE Na+/K+ Selectivity Check Solution

Electrode, Ion Specific, Sodium

External Water Supply Module

Catalogue number 115-005403-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

ISE Sodium Electrode

ISE Sodium Electrode for use with EasyElectrolyte Analyzers

Electrode, Ion Specific, Sodium

Water Supply Unit

Catalogue number 115-022519-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Electrode, Ion Specific, Sodium

Ready Sensor™ Gold Reference Sensor Inner Element

Ready Sensor™ GOLD Replacement reference Sensor Inner Element. An in vitro diagnostics device.

Electrode, Ion Specific, Sodium

RAPIDLab® 1200 Systems Reagent Cartridge

RAPIDLab® 1200 Systems Reagent Cartridge for in vitro diagnostics use with the RAPIDLab 1200 series systems.

Electrode, Ion Specific, Sodium

QC Rack Assembly

Catalogue number 801-BA80-00254-00, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Electrode, Ion Specific, Sodium. 2 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer