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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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The Randox Liquid Urine Control Level 2 is intended for in vitro diagnostic use, in the quality control of Amylase, Calcium, Chloride, Cortisol, Creatinine, Glucose, hCG pregnancy, Magnesium, Microalbumin, Osmolality, pH, Phosphate Inorganic, Potassium, Protein Total, Sodium, Specific Gravity, Urea and Uric Acid (Urate) on clinical chemistry systems. The Liquid Urine Control is for the control of accuracy.
RANDOX LABORATORIES LIMITED
UC5074
In Commercial Distribution

  • 05055273207569 ()


  • Multiple urine analyte IVD, control
This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert.
RANDOX LABORATORIES LIMITED
IA3110
In Commercial Distribution

  • 05055273207262 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
RANDOX LABORATORIES LIMITED
LUN5048
In Commercial Distribution

  • 05055273207118 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
RANDOX LABORATORIES LIMITED
UN1557
In Commercial Distribution

  • 05055273206807 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
The Randox Ammonia Ethanol Control - Level 2 is intended for in vitro diagnostic use, in the quality control of Ammonia and Alcohol Assays to monitor precision and to detect systematic analytical deviations on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
EA1367
In Commercial Distribution

  • 05055273202106 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
RANDOX LABORATORIES LIMITED
AU2352
In Commercial Distribution

  • 05055273200539 ()
AU2352

  • Multiple urine analyte IVD, control
No Description
ACCUTRON, INC.
34065
In Commercial Distribution

  • 00813830021929 ()
34065

  • Medical gas pipeline system
No Description
ACCUTRON, INC.
34064
In Commercial Distribution

  • 00813830021912 ()
34064

  • Medical gas pipeline system
No Description
Hausmann Enterprises, LLC
5557-100
In Commercial Distribution

  • 00840314806284 ()


  • General-purpose casework
Accu-Sed Plus ESR Controls are whole blood reference control materials designed to monitor patient erythrocyte sedimentation rate (ESR) procedures. Accu-Sed Plus Normal / Abnormal ESR Controls help to monitor technique as well as environmental, physical and mechanical factors such as room temperature, tube position, and vibration.
ELITECHGROUP INC.
DS-71006
In Commercial Distribution

  • 03661540304071 ()


  • Erythrocyte sedimentation rate (ESR) IVD, control
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