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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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Liquichek Diabetes Control Level 2 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
172
In Commercial Distribution

  • 00847661000846 ()
172

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 1 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
171
In Commercial Distribution

  • 00847661000839 ()
171

  • Glycated haemoglobin (HbA1c) IVD, control
Lumipulse G B-Amyloid Controls (Plasma)-N
FUJIREBIO INC.
235485
Not in Commercial Distribution

  • 04987270235485 ()

  • 4 bottles per unit; 1.0mLs per bottle


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay
Lumipulse G B-Amyloid 1-42-N Plasma IRC
FUJIREBIO INC.
235447
In Commercial Distribution

  • 04987270235447 ()

  • 42 Tests per Kit


  • Tau protein IVD, kit, chemiluminescent immunoassay
  • Amyloid B component IVD, kit, chemiluminescent immunoassay
UF ll CALIBRATOR
SYSMEX CORPORATION
06404310
In Commercial Distribution

  • 04987562408535 ()
  • 84987562408531 ()


  • Urine sediment IVD, calibrator
UF-CONTROL contains control particles for use in quality control measurement procedure of the Sysmex Fully Automated Urine Particle Analyzers and the Sysmex Fully Automated Urine Particle Digital Imaging Device.
SYSMEX CORPORATION
06404115
In Commercial Distribution

  • 04987562408528 ()

  • Total Volume: 47 Milliliter


  • Buffered sample diluent IVD
Aution AU Control Solution is supplied in 2 different levels (High and Low) and is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry model. (Primary UPC/EAN-13# 4987486738060 is used as the assigned UDI for the Class I device.)
ARKRAY USA, INC.
73806
In Commercial Distribution

  • 04987486738060 ()


  • Multiple urine analyte IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
991-06201
In Commercial Distribution

  • 04987481164673 ()
991-06201

  • Albumin IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-06001
In Commercial Distribution

  • 04987481164666 ()
999-06001

  • Albumin IVD, kit, nephelometry/turbidimetry
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
991-43701
In Commercial Distribution

  • 04987481164659 ()
991-43701

  • Total complement activity (CH50) IVD, control
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