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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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ALB - 05055273208115

An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum.
RANDOX LABORATORIES LIMITED
AB8301
In Commercial Distribution

  • 05055273208115 ()
AB8301

  • Albumin IVD, reagent

TF - 05055273206494

A Transferrin test system is a device intended for the quantitative in vitro determination of transferrin concentration in serum.
RANDOX LABORATORIES LIMITED
TF3831
In Commercial Distribution

  • 05055273206494 ()
TF3831

  • Transferrin/transferrin isoform IVD, kit, nephelometry/turbidimetry

mALB - 05055273204568

A Microalbumin test system is a device intended for the quantitative in vitro determination of Microalbumin concentration in urine
RANDOX LABORATORIES LIMITED
MA3828
In Commercial Distribution

  • 05055273204568 ()
MA3828

  • Microalbumin IVD, kit, nephelometry/turbidimetry

IgE CAL SET - 05055273203912

This product is intended for in vitro diagnostic use in the quality control of IgE on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
IE2492
In Commercial Distribution

  • 05055273203912 ()
IE2492

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, calibrator

CRP CAL - 05055273201727

The device is intended for in vitro diagnostic use in the calibration of CRP assays on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
CP2499
In Commercial Distribution

  • 05055273201727 ()
CP2499

  • C-reactive protein (CRP) IVD, calibrator

CRP CAL - 05055273201697

The device is intended for in vitro diagnostic use in the calibration of CRP assays on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
CP2479
In Commercial Distribution

  • 05055273201697 ()
CP2479

  • C-reactive protein (CRP) IVD, calibrator

hsCRP CAL - 05055273201680

The device is intended for in vitro diagnostic use in the calibration of CRP assays on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
CP2478
In Commercial Distribution

  • 05055273201680 ()
CP2478

  • C-reactive protein (CRP) IVD, calibrator

CRP CAL - 05055273201659

The device is intended for in vitro diagnostic use in the calibration of CRP assays on clinical chemistry systems.
RANDOX LABORATORIES LIMITED
CP2179
In Commercial Distribution

  • 05055273201659 ()
CP2179

  • C-reactive protein (CRP) IVD, calibrator

BIL - 05055273200867

The device is intended for the quantitative in vitro determination of total and direct bilirubin in serum or plasma.
RANDOX LABORATORIES LIMITED
BR412
In Commercial Distribution

  • 05055273200867 ()
BR412

  • Total bilirubin IVD, reagent
  • Conjugated (direct) bilirubin IVD, reagent

BIL - 05055273200850

The device is intended for the quantitative in vitro determination of total and direct bilirubin in serum or plasma.
RANDOX LABORATORIES LIMITED
BR411
In Commercial Distribution

  • 05055273200850 ()
BR411

  • Conjugated (direct) bilirubin IVD, reagent
  • Total bilirubin IVD, reagent
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