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 Class Implantable

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No Description
RANDOX LABORATORIES LIMITED
LP3864
In Commercial Distribution

  • 05055273204476 ()


  • Apolipoprotein E (Apo E) IVD, kit, nephelometry/turbidimetry
No Description
RANDOX LABORATORIES LIMITED
LO3998
In Commercial Distribution

  • 05055273204315 ()


  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetry
The Randox Ammonia Ethanol Control - Level 3 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
EA1368
In Commercial Distribution

  • 05055273202113 ()


  • 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
The Randox Ammonia Ethanol Control Level 1 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
EA1366
In Commercial Distribution

  • 05055273202090 ()


  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
RANDOX LABORATORIES LIMITED
AM1054
In Commercial Distribution

  • 05055273200263 ()
AM1054

  • Ammonia IVD, kit, enzyme spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
AM1015
In Commercial Distribution

  • 05055273200256 ()
AM1015

  • Ammonia IVD, kit, enzyme spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
AL7904
In Commercial Distribution

  • 05055273200232 ()
AL7904

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
AL2360
In Commercial Distribution

  • 05055273200195 ()
AL2360

  • Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometry
No Description
RANDOX LABORATORIES LIMITED
AL146
In Commercial Distribution

  • 05055273200188 ()
AL146

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry
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