FDA.reportPublic FDA data

Ionized Calcium Electrode

Primary DI
00811403010134
Brand
Ionized Calcium Electrode
Company
Diamond Diagnostics Inc.
Model
AV-BP0360D
Device description
Measuring concentration of ionized Calcium in whole blood, serum, and plasma samples.
Published
2023-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JFPElectrode, Ion Specific, Calcium

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFPElectrode, Ion Specific, CalciumClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811403010134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811403010134008114030101348114030101340811403010134

GMDN Terms#

Term, Definition table
TermDefinition
Calcium (Ca2+) electrode IVDAn electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of calcium (Ca2+) ions in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
947514303
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811403010158Photometer LampOY-MU8550D2023-06-13
00811403010240Reference SolutionIL-09756904D2023-06-13
00811403013074Pump Tubing KitCD-105673D2023-06-13
00811403013173C1/C2 Cleaning SolutionCD-473389D2023-06-13
00811403010387Wash PackCD-473497D2023-06-13
00811403013296pH ElectrodeCD-476267D2023-06-13
00811403013302Calcium ElectrodeCD-476268D2023-06-13
00811403013319Potassium ElectrodeCD-476270D2023-06-13
00811403013326Reference ElectrodeCD-476273D2023-06-13
00811403013333Chloride ElectrodeCD-476279D2023-06-13
00811403013371Fill SolutionCD-478533D2023-06-13
00811403013388Na-K-Ca-Cl Fill SolutionCD-478535D2023-06-13
00811403013456Conditoner SolutionCD-478701D2023-06-13
00811403013463Reference SolutionCD-478822D2023-06-13
00811403013609Printer PaperCD-67252D2023-06-13
00811403013630Pump TubingCD-673705D2023-06-13
00811403014040Salt Bridge SolutionDA-D105D2023-06-13
00811403014217Quick IMT Sample DiluentDA-S635D2023-06-13
00811403014224Quick IMT Diluent CheckDA-S640D2023-06-13
00811403015504Maintenance KitHM-XEA328ASD2023-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811403015924Calcium ElectrodeDiamond Diagnostics Inc.JFP2023-06-05
04015630028696Roche 9180 Calcium electrodeRoche Diagnostics GmbHJFP2021-07-30
00630414609515iCa++ Quick™ SamplerSiemens Healthcare Diagnostics Inc.JFP2020-12-15
00630414606460epoc Host2Epocal IncJFP2020-07-15
00630414286143RAPIDPoint® 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc.JFP2020-04-15
00894472000251E-Ca Cassette CartonOPTI MEDICAL SYSTEMS, INC.JFP2019-09-03
00386100002596pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONJFP2018-12-05
00386100002602Calcium ElectrodeMEDICA CORPORATIONJFP2018-12-05
00386100002633Bi-Level QC Kit, HCTMEDICA CORPORATIONJFP2018-12-05
00386100002664Reagent ModuleMEDICA CORPORATIONJFP2018-12-05
00386100002930Na/K/Cl/Ca/Li AnalyzerMEDICA CORPORATIONJFP2018-12-05
00386100003128Na/K/Cl/Ca/Li Solution packMEDICA CORPORATIONJFP2018-12-05
00386100003739pH/pCO2/pO2/Na/K/Ca AnalyzerMEDICA CORPORATIONJFP2018-12-05
00386100003159Calcium Reference Electrode MEDICA CORPORATIONJFP2018-12-04
00386100003135Calcium ElectrodeMEDICA CORPORATIONJFP2018-11-08
05700699439062S5362 REF 943-906Radiometer Medical ApSJFP2018-09-21
05700699441300Rinse Solution S4980 REF 944-130Radiometer Medical ApSJFP2018-09-21
15700699441369S8377 REF 944-136 *6 Cleaning solution Met II SoluRadiometer Medical ApSJFP2018-09-21
05700699441553Rinse Solution II S4987 REF 944-155 600mLRadiometer Medical ApSJFP2018-09-21
00385480528573STAT PROFILENOVA BIOMEDICAL CORPORATIONJFP2017-07-06
00630414053455RAPIDLab® 348 6.8/7.3 Buffer PackSiemens Healthcare Diagnostics Inc.JFP2016-09-24
00630414443492RAPIDPoint® 400 Measurement CartridgeSiemens Healthcare Diagnostics Inc.JFP2016-09-24
00630414515571RAPIDLab® 1200 Series 1265Siemens Healthcare Diagnostics Inc.JFP2016-09-24
00630414566238RAPIDPOINT® 340 Sensor ModuleSiemens Healthcare Diagnostics Inc.JFP2016-09-24
00630414566313RAPIDPOINT® 350 Sampler ModuleSiemens Healthcare Diagnostics Inc.JFP2016-09-24
00630414568584RAPIDPOINT® 340 Sampler ModuleSiemens Healthcare Diagnostics Inc.JFP2016-09-24
00630414570495RAPIDLab® 1200 pH Electrode FillSiemens Healthcare Diagnostics Inc.JFP2016-09-24
00630414570501RAPIDLab® 1200 Na+/K+/Ca++/CL- Electrode FillSiemens Healthcare Diagnostics Inc.JFP2016-09-24
04015630031832Roche 9180 Electrolyte AnalyzerRoche Diagnostics GmbHJFP2016-09-20
10385480152119NOVANOVA BIOMEDICAL CORPORATIONJFP2016-09-20