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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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For the quantitative in vitro determination of cholesterol in serum and plasma.
RANDOX LABORATORIES LIMITED
CH8310
In Commercial Distribution

  • 05055273208474 ()


  • Total cholesterol lipid IVD, kit, spectrophotometry
For the quantitative in vitro determination of IgM in serum and plasma
RANDOX LABORATORIES LIMITED
IM7977
In Commercial Distribution

  • 05055273204025 ()
IM7977

  • Total immunoglobulin M (IgM total) IVD, antibody
For the quantitative in vitro determination of IgM in serum and plasma
RANDOX LABORATORIES LIMITED
IM3834
In Commercial Distribution

  • 05055273204001 ()
IM3834

  • Total immunoglobulin M (IgM total) IVD, antibody
For the quantitative in vitro determination of D-3-Hydroxybutyrate in serum and plasma.
RANDOX LABORATORIES LIMITED
RB4067
In Commercial Distribution

  • 05055273215588 ()
RB4067

  • Beta-hydroxybutyrate dehydrogenase IVD, kit, spectrophotometry
For the quantitative in vitro determination of D-3-Hydroxybutyrate in serum and plasma.
RANDOX LABORATORIES LIMITED
RB8378
In Commercial Distribution

  • 05055273215571 ()
RB8378

  • Beta-hydroxybutyrate dehydrogenase IVD, kit, spectrophotometry
For the quantitative in vitro determination of triglycerides in serum or plasma.
RANDOX LABORATORIES LIMITED
TR3823
In Commercial Distribution

  • 05055273206647 ()


  • Triglyceride IVD, kit, spectrophotometry
For the quantitative in vitro determination of Triglycerides in serum and plasma.
RANDOX LABORATORIES LIMITED
TR210
In Commercial Distribution

  • 05055273206593 ()


  • Triglyceride IVD, kit, spectrophotometry
For the quantitative in vitro determination of Valproic Acid in human serum
RANDOX LABORATORIES LIMITED
TD3414
In Commercial Distribution

  • 05055273206456 ()
TD3414

  • Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Intended for the quantitative in vitro determination of Phenobarbital in human serum.
RANDOX LABORATORIES LIMITED
TD3408
In Commercial Distribution

  • 05055273206401 ()
TD3408

  • Phenobarbital IVD, kit, enzyme immunoassay (EIA)
For the quantitative in vitro determination of Potassium in serum or plasma.
RANDOX LABORATORIES LIMITED
PT7168
In Commercial Distribution

  • 05055273204940 ()
PT7168

  • Potassium (K+) IVD, reagent
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