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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

ISE Calibrator High - 00811403011810

ISE Calibrator High for Biotecnica Targa 3000,3000+
Diamond Diagnostics Inc.
BT-6620944D
In Commercial Distribution

  • 00811403011803 ()
  • 00811403011810 ()


  • Multiple electrolyte IVD, calibrator

ISE Calibrator Low - 00811403011797

ISE Calibrator Low for Biotecnica Targa 3000,3000+
Diamond Diagnostics Inc.
BT-6620943D
In Commercial Distribution

  • 00811403011780 ()
  • 00811403011797 ()


  • Multiple electrolyte IVD, calibrator

Calibrator, Level 3 - 00811403011575

For the calibration of Na+, K+, Cl-, Ca++, tCO2, BUN, Glucose and Creatinine.
Diamond Diagnostics Inc.
BK-465910D
In Commercial Distribution

  • 00811403011575 ()


  • Multiple electrolyte IVD, calibrator

Calibrator, Level 2 - 00811403011568

For the calibration of Na+, K+, Cl-, Ca++, tCO2, BUN, Glucose and Creatinine.
Diamond Diagnostics Inc.
BK-465909D
In Commercial Distribution

  • 00811403011568 ()


  • Multiple electrolyte IVD, calibrator

Calibrator, Level 1 - 00811403011551

For the calibration of Na+, K+, Cl-, Ca++, tCO2, BUN, Glucose and Creatinine.
Diamond Diagnostics Inc.
BK-465908D
In Commercial Distribution

  • 00811403011551 ()


  • Multiple electrolyte IVD, calibrator

BUN Reagent - 00811403011124

For the quantitative determination of urea nitrogen in serum or plasma.
Diamond Diagnostics Inc.
BK-443350D
In Commercial Distribution

  • 00811403011124 ()


  • Multiple electrolyte IVD, calibrator

Creatinine Reagent - 00811403011117

For quantitative determination of creatinine in serum and urine.
Diamond Diagnostics Inc.
BK-443340D
In Commercial Distribution

  • 00811403011117 ()


  • Multiple electrolyte IVD, calibrator

CO2 Alkaline Buffer - 00811403011087

For the quantitative determination of total CO2 in serum and plasma.
Diamond Diagnostics Inc.
BK-443320D
In Commercial Distribution

  • 00811403011087 ()


  • Multiple electrolyte IVD, calibrator

Fluid Pack - 00811403010486

To provide calibration points for the Sodium, Potassium, Chloride, Calcium and Lithium Electrodes.
Diamond Diagnostics Inc.
AV-BP5186D
In Commercial Distribution

  • 00811403010486 ()


  • Multiple electrolyte IVD, calibrator

Fluid Pack - 00811403010462

To provide calibration points for the Sodium, Potassium, Chloride, Calcium and Lithium Electrodes.
Diamond Diagnostics Inc.
AV-BP5032D
In Commercial Distribution

  • 00811403010462 ()


  • Multiple electrolyte IVD, calibrator

Fluid Pack - 00811403010417

To provide calibration points for the Sodium, Potassium, Chloride, Calcium and Lithium Electrodes.
Diamond Diagnostics Inc.
AV-BP5016D
In Commercial Distribution

  • 00811403010417 ()


  • Multiple electrolyte IVD, calibrator

Standard B Solution - 00811403010172

To provide calibration points for the Na, K & Cl electrodes for AVL 982, 983 Analyzers.
Diamond Diagnostics Inc.
AV-BP0442D
In Commercial Distribution

  • 00811403010172 ()


  • Multiple electrolyte IVD, calibrator

PreciControl Maternal Care - 07613336164358

No Description
Roche Diagnostics GmbH
08740062160
In Commercial Distribution

  • 07613336164358 ()
08740062160

  • Multiple human hormone IVD, control

Audit MicroControls Linearity FLQ Fertility Siemens Atellica/Centaur - B085K818M50

No Description
AALTO SCIENTIFIC
K818M-5
In Commercial Distribution

  • B085K818M50 ()


  • Multiple human hormone IVD, control

Audit MicroControls Linearity FD Fertility Siemens Centaur - B085K808M50

No Description
AALTO SCIENTIFIC
K808M-5
In Commercial Distribution

  • B085K808M50 ()


  • Multiple human hormone IVD, control

Audit MicroControls Cal Ver LQ Blood Gas - B085K727M50

No Description
AALTO SCIENTIFIC
K727M-5
In Commercial Distribution

  • B085K727M50 ()


  • Multiple blood gas analyte IVD, control

Audit MicroControls Linearity FLQ Fertility for Abbott Systems - B085K947M50

No Description
AALTO SCIENTIFIC
K947M-5
In Commercial Distribution

  • B085K947M50 ()


  • Multiple human hormone IVD, control

Audit MicroControls Linearity FLQ Fertility for Roche Systems - B085K927M50

No Description
AALTO SCIENTIFIC
K927M-5
In Commercial Distribution

  • B085K927M50 ()


  • Multiple human hormone IVD, control

CATECHOLAMINES LEVEL 3 - B800202090

CATECHOLAMINES LEVEL 3
UTAK LABORATORIES, INC.
20209
In Commercial Distribution

  • B800202095 ()
  • B800202090 ()

  • Total Volume: 2 Milliliter
20209

  • Multiple human hormone IVD, control

CATECHOLAMINES LEVEL 2 - B800202080

CATECHOLAMINES LEVEL 2
UTAK LABORATORIES, INC.
20208
In Commercial Distribution

  • B800202085 ()
  • B800202080 ()

  • Total Volume: 2 Milliliter
20208

  • Multiple human hormone IVD, control
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