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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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ARTHROSCOPY PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJV0266F
In Commercial Distribution

  • 40193489459808 ()
  • 10193489459807 ()
DYNJV0266F

  • General surgical procedure kit, non-medicated, single-use
The Randox Liquid Urine Control - Level 3 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
UC5075
In Commercial Distribution

  • 05055273207576 ()


  • Multiple urine analyte IVD, control
The Cystatin C Control is intended for use with in vitro diagnostic assays for the quantitative determination of Cystatin C. Cystatin C Control is assayed with target values, and it is suitable for use on automated analysers.
RANDOX LABORATORIES LIMITED
CYS5020
In Commercial Distribution

  • 05055273207422 ()


  • Cystatin C IVD, control
The Cystatin C Control is intended for use with in vitro diagnostic assays for the quantitative determination of Cystatin C. Cystatin C Control is assayed with target values and it is suitable for use on automated analysers.
RANDOX LABORATORIES LIMITED
CYS5019
In Commercial Distribution

  • 05055273207415 ()


  • Cystatin C IVD, control
This product is intended for in vitro diagnostic use, in the quality control of the accuracy of Immunoassays on clinical chemistry systems. This material can be used to monitor the control of accuracy or the control of reproducibility of immunoassays.
RANDOX LABORATORIES LIMITED
IAS3119
In Commercial Distribution

  • 05055273207347 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
This product is intended for in vitro diagnostic use, in the quality control of the accuracy of Immunoassays on clinical chemistry systems. This material can be used to monitor the control of accuracy or the control of reproducibility of immunoassays.
RANDOX LABORATORIES LIMITED
IAS3117
In Commercial Distribution

  • 05055273207323 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
This product is intended for in vitro diagnostic use, in the quality control of the accuracy of Immunoassays on clinical chemistry systems. This material can be used to monitor the control of accuracy or the control of reproducibility of immunoassays.
RANDOX LABORATORIES LIMITED
IAS3114
In Commercial Distribution

  • 05055273207309 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
This product is intended for in vitro diagnostic use, in the quality control of the accuracy of Immunoassays on clinical chemistry systems. This material can be used to monitor the control of accuracy or the control of reproducibility of immunoassays.
RANDOX LABORATORIES LIMITED
IAS3113
In Commercial Distribution

  • 05055273207293 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
SPINE PACK
MEDLINE INDUSTRIES, INC.
DYNJ67959
In Commercial Distribution

  • 40193489459426 ()
  • 10193489459425 ()
DYNJ67959

  • General surgical procedure kit, non-medicated, single-use
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
IA3111
In Commercial Distribution

  • 05055273207279 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
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