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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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BENZ - 05055273208023

The Benzodiazepine assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of Benzodiazepines in human urine
RANDOX LABORATORIES LIMITED
DA4009
In Commercial Distribution

  • 05055273208023 ()
DA4009

  • Benzodiazepine group IVD, reagent

BARB - 05055273208016

The Barbiturates assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of Barbiturates in human urine.
RANDOX LABORATORIES LIMITED
DA4008
In Commercial Distribution

  • 05055273208016 ()
DA4008

  • Barbiturate IVD, reagent

METHAMP - 05055273208009

The Methamphetamine assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of methamphetamine in human urine.
RANDOX LABORATORIES LIMITED
DA4007
In Commercial Distribution

  • 05055273208009 ()
DA4007

  • Amphetamine/methamphetamine group IVD, reagent

mALB - 05055273204551

A Microalbumin test system is a device intended for the quantitative in vitro determination of Microalbumin concentration in human urine
RANDOX LABORATORIES LIMITED
MA2864
In Commercial Distribution

  • 05055273204551 ()
MA2864

  • Microalbumin IVD, kit, nephelometry/turbidimetry

Albustix® Reagent Strips - 00630414550602

ALBUSTIX® are intended for in vitro diagnostic use by healthcare professionals to detect the presence of protein in urine.
Siemens Healthcare Diagnostics Inc.
10333485
In Commercial Distribution

  • 00630414550602 ()
  • 00630414009650 ()
A2191B16

  • Urine protein IVD, kit, rapid colorimetric, clinical

N.A. - J011380704500

Universal silver solder in rolls / in coils / without flux / cadmium free / Working temperature 700 °C / 1292 °F / Weight 10 g
DENTAURUM GmbH & Co.KG
380-704-50
In Commercial Distribution

  • J011380704500 ()


  • Dental brazing alloy

D LDL/HDL CAL - 05055273201239

The device is intended for in vitro diagnostic use in the calibration of Randox HDL and LDL cholesterol clearance methods
RANDOX LABORATORIES LIMITED
CH2673
In Commercial Distribution

  • 05055273201239 ()
CH2673

  • High density lipoprotein (HDL) cholesterol IVD, calibrator
  • Low density lipoprotein (LDL) cholesterol IVD, calibrator

AST - 05055273200508

The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotransferase (AST) in serum or plasma.
RANDOX LABORATORIES LIMITED
AS7938
In Commercial Distribution

  • 05055273200508 ()
AS7938

  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent

AST - 05055273200492

The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotransferase (AST) in serum or plasma.
RANDOX LABORATORIES LIMITED
AS7905
Not in Commercial Distribution

  • 05055273200492 ()
AS7905

  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent

AST - 05055273200485

The AST test system is intended for the quantitative in vitro determination of Aspartate Aminotransferase (AST) in serum or plasma.
RANDOX LABORATORIES LIMITED
AS3876
In Commercial Distribution

  • 05055273200485 ()
AS3876

  • Aspartate aminotransferase (AST) isoenzyme IVD, reagent
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