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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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CELL-DYN 26 PLUS CONTROL
ABBOTT LABORATORIES
08H59-02
In Commercial Distribution

  • 00380740017118 ()
08H5902

  • Full blood count IVD, control
CELL-DYN 26 PLUS CONTROL
ABBOTT LABORATORIES
08H59-01
In Commercial Distribution

  • 00380740017101 ()
08H5901

  • Full blood count IVD, control
CELL-DYN 29 PLUS CONTROL (with Retic)
ABBOTT LABORATORIES
08H58-02
In Commercial Distribution

  • 00380740017095 ()
08H5802

  • Full blood count IVD, control
CELL-DYN 29 PLUS CONTROL (with Retic)
ABBOTT LABORATORIES
08H58-01
In Commercial Distribution

  • 00380740017088 ()
08H5801

  • Full blood count IVD, control
CELL-DYN HemCal Plus Calibrator
ABBOTT LABORATORIES
08H57-01
In Commercial Distribution

  • 00380740017071 ()
08H5701

  • Full blood count IVD, calibrator
Qualitative multiplex polymerase chain reaction (PCR) test intended to detect the deletion of mononucleotides in 5 microsatellite loci (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) using matched tumor and normal DNA obtained from formalin fixed paraffin-embedded (FFPE) colorectal tissue sections.
PROMEGA CORPORATION
MD2140
In Commercial Distribution

  • 00849811031717 ()
MD2140

  • Microsatellite instability IVD, kit, nucleic acid technique (NAT)
VERSANT® Tissue Preparation Reagents (Box 3)
Siemens Healthcare Diagnostics Inc.
10632400
Not in Commercial Distribution

  • 00630414588810 ()
10632400

  • Nucleic acid extraction/isolation kit IVD
Liquichek Diabetes Control Trilevel MiniPak (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
292X
In Commercial Distribution

  • 00847661004301 ()
292X

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 3 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
293
In Commercial Distribution

  • 00847661004295 ()
293

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 2 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
292
In Commercial Distribution

  • 00847661004288 ()
292

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 1 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
291
In Commercial Distribution

  • 00847661004271 ()
291

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level Trilevel MiniPak (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
172X
In Commercial Distribution

  • 00847661002192 ()
172X

  • Glycated haemoglobin (HbA1c) IVD, control
Liquichek Diabetes Control Level 3 (A human whole blood assayed diabetes control.)
BIO-RAD LABORATORIES, INC.
173
In Commercial Distribution

  • 00847661000853 ()
173

  • Glycated haemoglobin (HbA1c) IVD, control
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
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