FDA.reportPublic FDA data

Multiple electrolyte IVD, kit, ion-selective electrode (ISE)

Definition
A collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen, using an ion-selective electrode (ISE) method.
GUDID devices
27
Last updated
2019-07-07 17:12:54

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850229007324SelectaLyte (Sodium Electrode)AWARENESS TECHNOLOGY, INCORPORATED39102019-06-26
00850229007331SelectaLyte (Potassium Electrode)AWARENESS TECHNOLOGY, INCORPORATED39102019-06-26
00850229007348SelectaLyte (Chloride Electrode)AWARENESS TECHNOLOGY, INCORPORATED39102019-06-26
00842768014291Dimension® QuikLYTE® Multisensor Na+/K+/Cl-Siemens Healthcare Diagnostics Inc.104450582016-09-24
00842768030413Dimension Vista® V-LYTE® Integrated Multisensor Na+ / K+ / Cl-Siemens Healthcare Diagnostics Inc.104844292016-09-24
00852553007254Serum ISE Verifier KitVERICHEM LABORATORIES, INC.92502018-01-17
00817302023107CLC800 Chemistry Analyzer with ISE ModuleCAROLINA LIQUID CHEMISTRIES CORPORATIONCLC8002016-12-05
00817302023114CLC1600 Chemistry Analyzer with ISE ModuleCAROLINA LIQUID CHEMISTRIES CORPORATIONCLC16002016-12-05
00817302023121CLC6410 Chemistry Analyzer with or without ISECAROLINA LIQUID CHEMISTRIES CORPORATIONCLC64102016-12-05
00817302023152CLC720 Chemistry Analyzer w/ISECAROLINA LIQUID CHEMISTRIES CORPORATIONCLC7202016-12-19
00817302023169CLC480 Chemistry Analyzer W/ISECAROLINA LIQUID CHEMISTRIES CORPORATIONCLC480i2016-12-19
00811727012418Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDHI790-KCL2016-08-31
00811727012722Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDHI790-DIL2016-08-31
00811727012821Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDHI990-DIL2016-08-31
00811727012845Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDHI990-KCL2016-08-31
00630414112275TB2 pH/Na+ Test/Blank SensorSiemens Healthcare Diagnostics Inc.103110302016-09-24
00630414194455RAPIDLab® Na+/K+/Ca++/Cl- Electrode FillSiemens Healthcare Diagnostics Inc.103110472016-09-24
00630414210230ADVIA® Chemistry ISE Serum Standard SetSiemens Healthcare Diagnostics Inc.103119032016-09-24
00630414210247ADVIA® Chemistry ISE Urine Standard SetSiemens Healthcare Diagnostics Inc.103119042016-09-24
00630414451817RAPIDChem® 744 Na+K+Cl- Reagent ModuleSiemens Healthcare Diagnostics Inc.103090482016-09-24
00630414451824RAPIDChem® 754 Na+K+Li+ Reagent ModuleSiemens Healthcare Diagnostics Inc.103090932016-09-24
00630414452135Sensor Module Cl-Siemens Healthcare Diagnostics Inc.103090862016-09-24
00630414566238RAPIDPOINT® 340 Sensor ModuleSiemens Healthcare Diagnostics Inc.103758092016-09-24
00630414566290RAPIDPOINT® 350 Reagent ModuleSiemens Healthcare Diagnostics Inc.103758062016-09-24
00630414566306RAPIDPOINT® 340 Reagent ModuleSiemens Healthcare Diagnostics Inc.103758072016-09-24
00630414566337RAPIDPOINT® 350 Sensor ModuleSiemens Healthcare Diagnostics Inc.103758122016-09-24
00630414596518Atellica A-LYTE™ Integrated Multisensor Na+ / K+ / Cl-Siemens Healthcare Diagnostics Inc.110993152017-12-22