FDA.reportPublic FDA data

Ion selective electrode (ISE) reference solution IVD, reagent

Definition
A substance or reactant intended to be used together with a reference electrode to perform a specific function in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.
GUDID devices
49
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00811403011759ISE Reference Solution KitDiamond Diagnostics Inc.BT-6620941D2023-06-12
00853366007202PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.16-2272018-01-26
03701700800194ENVOY 500 ISE BASELINE SOLUTION KITVITALSCIENTIFIC553812025-03-31
03701700800224ENVOY 500 ISE REFERENCE SOLUTION KITVITALSCIENTIFIC553822025-03-31
03701700824305ISE REFERENCE SOLUTIONVITALSCIENTIFICISRS-08002025-03-31
07613336227794Reference electrodeRoche Diagnostics GmbH031495010012025-03-05
03661540202506ENVOY 500 ISE BASELINE SOLUTION KITVITALSCIENTIFIC553812016-09-24
03661540202803ENVOY 500 ISE REFERENCE SOLUTION KITVITALSCIENTIFIC553822016-09-24
03661540215605ISE REFERENCE SOLUTIONVITALSCIENTIFICISRS-08002016-09-24
00811403010240Reference SolutionDiamond Diagnostics Inc.IL-09756904D2023-06-13
00811403013371Fill SolutionDiamond Diagnostics Inc.CD-478533D2023-06-13
00811403013388Na-K-Ca-Cl Fill SolutionDiamond Diagnostics Inc.CD-478535D2023-06-13
00811403013463Reference SolutionDiamond Diagnostics Inc.CD-478822D2023-06-13
00811403014040Salt Bridge SolutionDiamond Diagnostics Inc.DA-D105D2023-06-13
00811403017010Internal Reference SolutionDiamond Diagnostics Inc.OY-AUH1017D2023-06-13
00811403011742ISE Reference Solution KitDiamond Diagnostics Inc.BT-6620941D2023-06-12
00811403011964ISE Reference ReagentDiamond Diagnostics Inc.BK-A17657D2023-06-12
00811403012589ISE Internal Reference SolutionDiamond Diagnostics Inc.BM-450042D2023-06-12
00811403011629ISE Reference ReagentDiamond Diagnostics Inc.BK-467935D2023-06-10
00811403018321ISE Internal StandardDiamond Diagnostics Inc.RO-4522320D2023-06-09
00811403018833Cal A SolutionDiamond Diagnostics Inc.AW-SA1021D2023-06-10
00842768004735Dimension® Salt Bridge SolutionSiemens Healthcare Diagnostics Inc.104448732020-09-24
04987762129803Lamp Coolant CJEOL LTD.7816114402020-09-15
00817302023206Carolina Liquid Chemistries Corp. ISE Diluent DT88810CAROLINA LIQUID CHEMISTRIES CORPORATIONDT888102020-05-08
00817302023213Carolina Liquid Chemistries Corp. ISE Internal Standard Solution DT88820CAROLINA LIQUID CHEMISTRIES CORPORATIONDT888202020-05-08
00817302023220Carolina Liquid Chemistries Corp. ISE Reference Solution DT88811CAROLINA LIQUID CHEMISTRIES CORPORATIONDT888112020-05-08
00380740163372ARCHITECTAbbott GmbH1E49-212019-08-15
00853366007189PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.16-2262018-01-26
10853366007209PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.16-2272018-01-26
05055273214338REF SOLNRANDOX LABORATORIES LIMITEDRX40452016-09-26
00851445007242GENCHEM™ ISE Electrolyte BufferGENCHEM INCGEN-ISE BUFFER2016-09-10
00851445007259GENCHEM™ ISE Electrolyte ReferenceGENCHEM INCGEN-ISE REFERENCE2016-09-10
00857969006327Alfa WassermannALFA WASSERMANN, INC.E1-32016-09-24
00857969006372Alfa WassermannALFA WASSERMANN, INC.E1-92016-09-24
00817302020663ISE ELECTROLYTE BUFFEER REAGENT KIT 88810CAROLINA LIQUID CHEMISTRIES CORPORATION888102016-09-01
00817302020670ISE ELECTROLYTE REFERENCE 88811CAROLINA LIQUID CHEMISTRIES CORPORATION888112016-09-01
00811727012401Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDHI790-REF2016-08-31
00811727012838Pointe Scientific, Inc.HORIBA INSTRUMENTS INCORPORATEDHI990-REF2016-08-31
00811727014757Pointe Scientific, Inc. ISE Internal ReferenceHORIBA INSTRUMENTS INCORPORATEDHI790-REF2016-08-31
00657498001783Reference SolutionSTANBIO LABORATORY, L.P.A469-992016-09-24
00630414112206Ready Sensor™ GOLD Reference SensorSiemens Healthcare Diagnostics Inc.103230842016-09-24
00630414114934Ready Sensor™ GOLD Reference Sensor RefillSiemens Healthcare Diagnostics Inc.103204582016-09-24
00630414115030Ready Sensor™ GOLD Reference Sensor Inner ElementSiemens Healthcare Diagnostics Inc.103299472016-09-24
00630414117539RAPIDLab® Reference Electrode FillSiemens Healthcare Diagnostics Inc.103110812016-09-24
00630414492636Ready Sensor™ GOLD Reference SensorSiemens Healthcare Diagnostics Inc.103243862016-09-24
00630414492643Ready Sensor™ GOLD Reference Sensor RefillSiemens Healthcare Diagnostics Inc.103243882016-09-24
00630414570501RAPIDLab® 1200 Na+/K+/Ca++/CL- Electrode FillSiemens Healthcare Diagnostics Inc.103768822016-09-24
00380740136512AlinityAbbott GmbH08P76402018-05-31
00386100003210Internal Filling SolutionMEDICA CORPORATION24922018-12-04