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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Na/K Selectivity Check Solution - 00811403016587

No Description
Diamond Diagnostics Inc.
OY-AUH1018D
In Commercial Distribution

  • 00811403016587 ()


  • Multiple electrolyte IVD, calibrator

Olympus AU ISE Calibrators - 00811403016570

For the quantitative determination of Na+, K+, and Cl- concentrations in human serum and urine on Olympus Analyzers.
Diamond Diagnostics Inc.
OY-AUH1016D
In Commercial Distribution

  • 00811403016570 ()


  • Multiple electrolyte IVD, calibrator

Olympus AU ISE Calibrators - 00811403016549

For the quantitative determination of Na+, K+, and Cl- concentrations in human serum and urine on Olympus Analyzers.
Diamond Diagnostics Inc.
OY-AUH1015D
In Commercial Distribution

  • 00811403016549 ()


  • Multiple electrolyte IVD, calibrator

Olympus AU ISE Calibrators - 00811403016532

For the quantitative determination of Na+, K+, and Cl- concentrations in human serum and urine on Olympus Analyzers.
Diamond Diagnostics Inc.
OY-AUH1014D
In Commercial Distribution

  • 00811403016532 ()


  • Multiple electrolyte IVD, calibrator

ISE Reference Solution - 00811403016525

ISE Reference Solution
Diamond Diagnostics Inc.
OY-AUH1013D
In Commercial Distribution

  • 00811403016525 ()


  • Multiple electrolyte IVD, calibrator

Olympus AU ISE Calibrators - 00811403016518

For the quantitative determination of Na+, K+, and Cl- concentrations in human serum and urine on Olympus Analyzers.
Diamond Diagnostics Inc.
OY-AUH1012D
In Commercial Distribution

  • 00811403016518 ()


  • Multiple electrolyte IVD, calibrator

ISE Buffer - 00811403016501

For the quantitative determination of Na+, K+, and Cl- concentrations in human serum and urine.
Diamond Diagnostics Inc.
OY-AUH1011D
In Commercial Distribution

  • 00811403016501 ()


  • Multiple electrolyte IVD, calibrator

Pack, 800mL, Na/K/Ca/pH - 00811403015917

Provide calibration points for the Na, K, Cl and Li electrodes.
Diamond Diagnostics Inc.
ME-2123D
In Commercial Distribution

  • 00811403015917 ()


  • Multiple blood gas analyte IVD, control

Standard A Solution - 00811403015900

To provide calibration points for the Na, K, and Cl electrodes on the Medica ISE Module Analyzer.
Diamond Diagnostics Inc.
ME-6370D
In Commercial Distribution

  • 00811403015900 ()


  • Multiple electrolyte IVD, calibrator

Pack, 800mL, Na/K/Cl - 00811403015894

Provide calibration points for the Na, K, Cl and Li electrodes.
Diamond Diagnostics Inc.
ME-2121D
In Commercial Distribution

  • 00811403015894 ()


  • Multiple blood gas analyte IVD, control

Standard B Solution - 00811403015887

To provide calibration points for the Na, K, and Cl electrodes on the Medica ISE Module Analyzer.
Diamond Diagnostics Inc.
ME-5410D
In Commercial Distribution

  • 00811403015887 ()


  • Multiple electrolyte IVD, calibrator

Fluid Pack - 00811403015672

Provide calibration points for the Na, K, Ca and pH electrodes.
Diamond Diagnostics Inc.
IL-2123D
In Commercial Distribution

  • 00811403015672 ()


  • Multiple blood gas analyte IVD, control

Fluid Pack - 00811403015665

Provide calibration points for the Na+, K+, Cl- and Li+ electrodes.
Diamond Diagnostics Inc.
IL-2121D
In Commercial Distribution

  • 00811403015665 ()


  • Multiple blood gas analyte IVD, control

Mission Trinity R, Level 1,2,3 - 00811403014873

For monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter (Radiometer) instrumentation for the analytes and analyzers listed on the Expected Values Chart.
Diamond Diagnostics Inc.
DD-97123
In Commercial Distribution

  • 00811403014873 ()


  • Multiple blood gas analyte IVD, control

Mission Trinity R, Level 3 - 00811403014866

For monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter (Radiometer) instrumentation for the analytes and analyzers listed on the Expected Values Chart.
Diamond Diagnostics Inc.
DD-97003
In Commercial Distribution

  • 00811403014866 ()


  • Multiple blood gas analyte IVD, control

Mission Trinity R, Level 2 - 00811403014859

For monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter (Radiometer) instrumentation for the analytes and analyzers listed on the Expected Values Chart.
Diamond Diagnostics Inc.
DD-97002
In Commercial Distribution

  • 00811403014859 ()


  • Multiple blood gas analyte IVD, control

Mission Trinity R, Level 1 - 00811403014842

For monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter (Radiometer) instrumentation for the analytes and analyzers listed on the Expected Values Chart.
Diamond Diagnostics Inc.
DD-97001
In Commercial Distribution

  • 00811403014842 ()


  • Multiple blood gas analyte IVD, control

Mission Trinity B Level 1-2-3 - 00811403014835

For monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter.
Diamond Diagnostics Inc.
DD-96123
In Commercial Distribution

  • 00811403014835 ()


  • Multiple blood gas analyte IVD, control

Mission Trinity B, Level 3 - 00811403014828

For monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter.
Diamond Diagnostics Inc.
DD-96003
In Commercial Distribution

  • 00811403014828 ()


  • Multiple blood gas analyte IVD, control

Mission Trinity B, Level 2 - 00811403014811

For monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter instrumentation for the analytes and analyzers listed on the Expected Values Chart.
Diamond Diagnostics Inc.
DD-96002
In Commercial Distribution

  • 00811403014811 ()


  • Multiple blood gas analyte IVD, control

Mission Trinity B, Level 1 - 00811403014804

For monitoring the performance of blood gas, electrolyte, metabolite, and CO-Oximeter.
Diamond Diagnostics Inc.
DD-96001
In Commercial Distribution

  • 00811403014804 ()


  • Multiple blood gas analyte IVD, control

Mission Control Linearity, 5 Levels - 00811403014798

Verification of pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose and lactate performance on the instrument.
Diamond Diagnostics Inc.
DD-92900
In Commercial Distribution

  • 00811403014798 ()


  • Multiple blood gas analyte IVD, control

Mission Control, Level 1-2-3 - 00811403014781

For quality control of pH, Blood Gas and Electrolyte Analyzers.
Diamond Diagnostics Inc.
DD-92123
In Commercial Distribution

  • 00811403014781 ()


  • Multiple blood gas analyte IVD, control

Mission Control, Level 3 - 00811403014767

For monitoring the performance of blood gas, electrolyte and metabolite instrumentation for the analysts and analyzers listed on the Expected Values Chart.
Diamond Diagnostics Inc.
DD-92003
In Commercial Distribution

  • 00811403014767 ()


  • Multiple blood gas analyte IVD, control

Mission Control, Level 2 - 00811403014750

For monitoring the performance of blood gas, electrolyte and metabolite instrumentation for the analysts and analyzers listed on the Expected Values Chart.
Diamond Diagnostics Inc.
DD-92002
In Commercial Distribution

  • 00811403014750 ()


  • Multiple blood gas analyte IVD, control

Mission Control, Level 1 - 00811403014743

For monitoring the performance of blood gas, electrolyte and metabolite instrumentation for the analysts and analyzers listed on the Expected Values Chart.
Diamond Diagnostics Inc.
DD-92001
In Commercial Distribution

  • 00811403014743 ()


  • Multiple blood gas analyte IVD, control

Buffer Pack - 00811403013180

To provide calibration points for the pH electrode.
Diamond Diagnostics Inc.
CD-473496D
In Commercial Distribution

  • 00811403010349 ()
  • 00811403013180 ()


  • Multiple electrolyte IVD, calibrator

Buffer Pack - 00811403013036

To provide calibration points for the Na+, K+, CI+, Ca++, pH, and hematocrit electrodes.
Diamond Diagnostics Inc.
CD-104227D
In Commercial Distribution

  • 00811403010325 ()
  • 00811403013036 ()


  • Multiple electrolyte IVD, calibrator

ISE Low Standard - 00811403012619

To provide calibration points for Na+, K+, and Cl- electrodes.
Diamond Diagnostics Inc.
BM-620428D
In Commercial Distribution

  • 00811403012619 ()


  • Multiple electrolyte IVD, calibrator

ISE High Standard - 00811403012602

To provide calibration points for Na+, K+, and Cl- electrodes.
Diamond Diagnostics Inc.
BM-620427D
In Commercial Distribution

  • 00811403012602 ()


  • Multiple electrolyte IVD, calibrator
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