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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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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

JAS Diagnostics - 00817274021354

CPK LIQUID (4 x 120mL R1, 1x 30mL R2)
DREW SCIENTIFIC, INC.
XL-CPK2-40
In Commercial Distribution

  • 00817274021354 ()


  • Total creatine kinase (CK) IVD, calibrator

JAS Diagnostics - 00817274021347

CPK LIQUID (1x 1L R1, 2x 125mL R2)
DREW SCIENTIFIC, INC.
CPK2-1L
In Commercial Distribution

  • 00817274021347 ()


  • Total creatine kinase (CK) IVD, calibrator

JAS Diagnostics - 00817274021330

CPK LIQUID (1x 120mL R1, 1x 30mL R2)
DREW SCIENTIFIC, INC.
CPK2-120
In Commercial Distribution

  • 00817274021330 ()


  • Total creatine kinase (CK) IVD, calibrator

JAS Diagnostics - 00817274021323

CPK LIQUID (1x 120mL R1, 1x 30mL R2)
DREW SCIENTIFIC, INC.
DG-CPK2-120
In Commercial Distribution

  • 00817274021323 ()


  • Total creatine kinase (CK) IVD, calibrator

K-ASSAY® Apo AI / B Control - 00816426021648

For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B.
KAMIYA BIOMEDICAL COMPANY, LLC
K310C-4M
In Commercial Distribution

  • 00816426021648 ()
K310C-4M

  • Multiple apolipoprotein IVD, control
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