FDA.report

Reference electrode IVD

Definition
An electrochemical sensor intended to be used as a known reference for electrical potential in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.
GUDID devices
33
Last updated
2025-04-08 13:14:43

Related Product Codes

CodeDeviceSpecialtyClassDevices
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry16
CEMElectrode, Ion Specific, PotassiumClinical Chemistry24
CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhClinical Chemistry24
JGSElectrode, Ion Specific, SodiumClinical Chemistry24
JJPElectrode, Ion Selective (Non-Specified)Clinical Chemistry13
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry22
JFPElectrode, Ion Specific, CalciumClinical Chemistry21
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
03701700829218Reference ElectrodeVITALSCIENTIFIC273-0012025-03-31
00811403013326Reference ElectrodeDiamond Diagnostics Inc.CD-476273D2023-06-13
00811403017089Reference ElectrodeDiamond Diagnostics Inc.OY-MU9197D2023-06-13
00811403011865Reference ElectrodeDiamond Diagnostics Inc.BM-373039D2023-06-12
00811403017713Reference ElectrodeDiamond Diagnostics Inc.RD-945389D2023-06-09
00811403017720Reference ElectrodeDiamond Diagnostics Inc.RD-945633D2023-06-09
00811403018772Reference ElectrodeDiamond Diagnostics Inc.AW-906179D2023-06-10
00811403010479Sample SensorDiamond Diagnostics Inc.AV-BP5036D2023-06-06
00811403015801Reference ElectrodeDiamond Diagnostics Inc.ME-2103D2023-06-06
00811403015849Solution ValveDiamond Diagnostics Inc.ME-2108D2023-06-06
00811403015931Sample DetectorDiamond Diagnostics Inc.ME-2257D2023-06-06
00811403015948Membrane AssemblyDiamond Diagnostics Inc.ME-2258D2023-06-06
00811403010424Reference Electrode HousingDiamond Diagnostics Inc.AV-BP5019D2023-06-05
00811403010448Reference ElectrodeDiamond Diagnostics Inc.AV-BP5026D2023-06-05
00630414478654ADVIA® Chemistry Systems Reference ElectrodeSiemens Healthcare Diagnostics Inc.103094652020-09-24
04987762129841Reference ElectrodeJEOL LTD.7816114072020-09-15
00853366007134PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.E-930AU2018-01-26
00853366007332PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.E-3302018-01-26
00853366007349PHOENIX DIAGNOSTICS, INC.PHOENIX DIAGNOSTICS, INC.E-3402018-01-26
05055273210552I.S.E. REFRANDOX LABORATORIES LIMITEDD200-00172016-09-24
05055273214895I.S.E. REFRANDOX LABORATORIES LIMITEDD400-00102016-09-26
05700699420589Membrane for E1001 electrodeRadiometer Medical ApS942-0582016-09-01
05700699420671Membrane for E155 electrodeRadiometer Medical ApS942-0672016-09-01
05700699456038Electrode for ABL analyzersRadiometer Medical ApS945-6032016-09-01
05700699456335Electrode for ABL analyzersRadiometer Medical ApS945-6332016-09-01
06944904024615Ref electrode,indirect,internationalShenzhen Mindray Bio-Medical Electronics Co., Ltd.040-000539-002016-09-23
00657498001875ISE Reference ElectrodeSTANBIO LABORATORY, L.P.202704732016-09-24
00630414451893RAPIDChem® 700 RAPIDPoint® 340/350 Reference SensorSiemens Healthcare Diagnostics Inc.103090342016-09-24
00630414482309ADVIA® 1650 Chemistry System Ref.Siemens Healthcare Diagnostics Inc.103094422018-12-01
00386100001650ISE Disposable Reference Electrode MEDICA CORPORATION52042018-12-11
00386100002985Reference ElectrodeMEDICA CORPORATION21032018-12-04
00386100003159Calcium Reference Electrode MEDICA CORPORATION21522018-12-04
00386100003173Membrane Assembly MEDICA CORPORATION22582018-12-04