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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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This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10430
In Commercial Distribution

  • 05055273217667 ()
CQ10430

  • Multiple cardiac marker IVD, control
This product is intended for in vitro use, in the quality control of Cardiac Markers on clinical chemistry and Immunoassay systems.
RANDOX LABORATORIES LIMITED
CQ10429
In Commercial Distribution

  • 05055273217650 ()
CQ10429

  • Multiple cardiac marker IVD, control
This product is intended for intended for use with in vitro diagnostic assays, for the quantitative determination of Troponin I. Cardiac Controls are unassayed without target values and are suitable for use on automated analysers. Cardiac Controls are for use by trained laboratory professionals and can be used in determining the precision of testing systems and in identifying sources of variation.
RANDOX LABORATORIES LIMITED
CQ10428
In Commercial Distribution

  • 05055273217346 ()
CQ10428

  • Multiple cardiac marker IVD, control
Intended for in vitro diagnostic (IVD) use as a quality control material for determination of Total Bilirubin and Direct Bilirubin on chemistry analysers. For use in a clinical laboratory setting by trained personnel.
RANDOX LABORATORIES LIMITED
BR10443
In Commercial Distribution

  • 05055273216837 ()
BR10443

  • Total bilirubin IVD, control
Intended for in vitro diagnostic (IVD) use as a quality control material for determination of Total Bilirubin and Direct Bilirubin on chemistry analysers. For use in a clinical laboratory setting by trained personnel.
RANDOX LABORATORIES LIMITED
BR10442
In Commercial Distribution

  • 05055273216820 ()
BR10442

  • Total bilirubin IVD, control
Clinical Chemistry Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of the Roche Systems for Albumin, BUN, Calcium, Total Cholesterol, Creatinine, Glucose, Lactate, Lithium, Magnesium, Phosphate, Total Protein, Triglycerides, Uric acid, Iron, Sodium, Potassium and Chloride assays.
RANDOX LABORATORIES LIMITED
LV10390
In Commercial Distribution

  • 05055273216684 ()
LV10390

  • Multiple-type clinical chemistry analyte profile IVD, control
Lipid Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Beckman Coulter AU Systems for HDL, LDL and Triglycerides.
RANDOX LABORATORIES LIMITED
LV10364
In Commercial Distribution

  • 05055273216455 ()
LV10364

  • Multiple lipid analyte IVD, control
Apolipoprotein A1 & B Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Beckman Coulter AU Systems for Apolipoprotein A1 and Apolipoprotein B.
RANDOX LABORATORIES LIMITED
LV10363
In Commercial Distribution

  • 05055273216448 ()
LV10363

  • Multiple apolipoprotein IVD, control
Apo Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Apo A1 and Apo B.
RANDOX LABORATORIES LIMITED
LV10357
In Commercial Distribution

  • 05055273216271 ()
LV10357

  • Multiple apolipoprotein IVD, control
Therapeutic Drug Markers (TDM) Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of the Roche Systems for Acetaminophen, Amikacin, Carbamazepine, Digoxin, Gentamicin, Lithium, N-Acetylprocainamide, Phenobarbital, Phenytoin, Procainamide, Quinidine, Salicylate, Theophylline, Tobramycin, Valproic Acid and Vancomycin assays.
RANDOX LABORATORIES LIMITED
LV10355
In Commercial Distribution

  • 05055273216264 ()
LV10355

  • Multiple therapeutic drugs/drugs of abuse IVD, control
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