FDA.reportPublic FDA data

Multiple electrolyte IVD, calibrator

Definition
A material which is used to establish known points of reference for a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.
GUDID devices
128
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00811403011797ISE Calibrator LowDiamond Diagnostics Inc.BT-6620943D2023-06-05
00811403011810ISE Calibrator HighDiamond Diagnostics Inc.BT-6620944D2023-06-05
00811403013036Buffer PackDiamond Diagnostics Inc.CD-104227D2023-06-05
00811403013180Buffer PackDiamond Diagnostics Inc.CD-473496D2023-06-05
00852676007759PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.3-7012018-02-15
00852676007766PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.3-7022018-02-15
00852676007780Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.3-6022020-03-28
00853366007011Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.21-1012017-08-12
00853366007028Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.21-1022017-08-12
00853366007035Phoenix Diagnostics, Inc.PHOENIX DIAGNOSTICS, INC.21-1032017-10-17
00853366007042Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.21-1042017-08-12
00853366007059Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.21-1052017-04-25
00853366007066PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.21-1062018-01-25
00853366007073PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.21-1072018-01-25
00853366007080PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.21-1082018-01-25
00853366007141Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.16-2002017-04-25
00853366007219Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.16-2052017-04-25
00853366007226Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.16-2062017-04-25
03701700800200ENVOY 500 ISE CALIBRATOR KITVITALSCIENTIFIC551172025-03-31
03701700824008ISE CALIBRATORSVITALSCIENTIFICISCA-02502025-03-31
03661540202605ENVOY 500 ISE CALIBRATOR KITVITALSCIENTIFIC551172016-09-24
03661540215308ISE CALIBRATORSVITALSCIENTIFICISCA-02502016-09-24
00811403016501ISE BufferDiamond Diagnostics Inc.OY-AUH1011D2023-06-07
00811403016525ISE Reference SolutionDiamond Diagnostics Inc.OY-AUH1013D2023-06-07
00811403017478Cal 2 SolutionDiamond Diagnostics Inc.RD-943839D2023-06-07
00811403018598Urine CalibratorDiamond Diagnostics Inc.TB-20270480D2023-06-07
00811403016587Na/K Selectivity Check SolutionDiamond Diagnostics Inc.OY-AUH1018D2023-06-13
00811403018529Calibrator 2Diamond Diagnostics Inc.TB-30270905D2023-06-09
00811403010172Standard B SolutionDiamond Diagnostics Inc.AV-BP0442D2023-06-05
00811403010325Buffer PackDiamond Diagnostics Inc.CD-104227D2023-06-05
00811403010349Buffer PackDiamond Diagnostics Inc.CD-473496D2023-06-05
00811403010417Fluid PackDiamond Diagnostics Inc.AV-BP5016D2023-06-05
00811403010462Fluid PackDiamond Diagnostics Inc.AV-BP5032D2023-06-05
00811403010486Fluid PackDiamond Diagnostics Inc.AV-BP5186D2023-06-05
00811403011087CO2 Alkaline BufferDiamond Diagnostics Inc.BK-443320D2023-06-05
00811403011117Creatinine ReagentDiamond Diagnostics Inc.BK-443340D2023-06-05
00811403011124BUN ReagentDiamond Diagnostics Inc.BK-443350D2023-06-05
00811403011551Calibrator, Level 1Diamond Diagnostics Inc.BK-465908D2023-06-05
00811403011568Calibrator, Level 2Diamond Diagnostics Inc.BK-465909D2023-06-05
00811403011575Calibrator, Level 3 Diamond Diagnostics Inc.BK-465910D2023-06-05
00811403011780ISE Calibrator LowDiamond Diagnostics Inc.BT-6620943D2023-06-05
00811403011803ISE Calibrator HighDiamond Diagnostics Inc.BT-6620944D2023-06-05
00811403012602ISE High StandardDiamond Diagnostics Inc.BM-620427D2023-06-05
00811403012619ISE Low StandardDiamond Diagnostics Inc.BM-620428D2023-06-05
00811403015887Standard B SolutionDiamond Diagnostics Inc.ME-5410D2023-06-05
00811403015900Standard A SolutionDiamond Diagnostics Inc.ME-6370D2023-06-05
00811403016518Olympus AU ISE CalibratorsDiamond Diagnostics Inc.OY-AUH1012D2023-06-05
00811403016532Olympus AU ISE CalibratorsDiamond Diagnostics Inc.OY-AUH1014D2023-06-05
00811403016549Olympus AU ISE CalibratorsDiamond Diagnostics Inc.OY-AUH1015D2023-06-05
00811403016570Olympus AU ISE CalibratorsDiamond Diagnostics Inc.OY-AUH1016D2023-06-05
008114030173487.4 Cal SolutionDiamond Diagnostics Inc.RD-943837D2023-06-05
008114030173556.8 Cal SolutionDiamond Diagnostics Inc.RD-973792D2023-06-05
00811403017461Cal 1 Solution Diamond Diagnostics Inc.RD-943837D2023-06-05
00811403018567ISE Calibrator 1Diamond Diagnostics Inc.TB-20270477D2023-06-05
00811403018574ISE Calibrator 2Diamond Diagnostics Inc.TB-20270478D2023-06-05
00811403019021ISE Serum StandardDiamond Diagnostics Inc.SM-B03417501D2023-06-05
00811403019038ISE Serum StandardDiamond Diagnostics Inc.SM-B03417601D2023-06-05
00380740163358ARCHITECTAbbott GmbH1E47-032019-08-15
00386100002282ISE Reagent PackMEDICA CORPORATION5423-00412019-02-14
00857969006648ACEALFA WASSERMANN, INC.SA10272020-04-09
00852676009784Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.3-6022020-03-28
08426950086796Flame photometer standard 160 Na 8KINSTRUMENTATION LABORATORY COMPANY000097519502016-09-23
00852676009753PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.3-7022018-02-15
00852676009760PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.3-7012018-02-15
00853366007363Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.23-1012017-08-14
00853366007370Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.23-1022017-08-14
00853366007462Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.4-1302017-04-25
00853366007486Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.4-1802017-08-12
00853366007554PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.15-1812018-02-15
00853366007578PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.19-0052018-02-15
00853366007585PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.19-0062018-02-15
00853366007608Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.19-0072017-08-12
00853366007615Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.19-007S2017-08-12
00853366007691PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.13-0052018-01-25
00853366007707PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.13-0112018-01-25
00853366007721PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.13-0022018-01-25
00853366007776PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.19-007D2018-02-15
00853366007783PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.23-2022018-01-26
10853366007025Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.21-1022017-08-12
10853366007032Phoenix Diagnostics, Inc.PHOENIX DIAGNOSTICS, INC.21-1032017-10-17