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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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The Local Run Manager CF 139 Variant analysis module is for use with Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay. The assay detects 139 clinically relevant cystic fibrosis disease-causing mutations and variants of the cystic fibrosis transmembrane conductance regulator (CFTR) gene in genomic DNA isolated from human peripheral whole blood specimens. The analysis module performs secondary analysis and report generation from sequencing runs that use the MiSeqDx Cystic Fibrosis 139-Variant Assay.
ILLUMINA, INC.
20047009
In Commercial Distribution

  • 00816270020286 ()
20047009

  • Cystic fibrosis IVD, kit, multiplex
The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay consists of library preparation and sample indexing reagents, sequencing reagents and consumables, MiSeqDx instrument and data analysis software. MiSeqDx Cystic Fibrosis 139 Variant Assay (2 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15041293 MiSeqDx Cystic Fibrosis 139 Variant Assay 1/5 15041291 MiSeqDx Cystic Fibrosis 139 Variant Assay 1A 15041292 MiSeqDx Cystic Fibrosis 139 Variant Assay 1B 15041294 MiSeqDx Cystic Fibrosis 139 Variant Assay 2/5 15041297 MiSeqDx Cystic Fibrosis 139 Variant Assay 3/5 15041295 MiSeqDx Cystic Fibrosis 139 Variant Assay 3A 15041296 MiSeqDx Cystic Fibrosis 139 Variant Assay 3B 15041298 MiSeqDx Cystic Fibrosis 139 Variant Assay Box 4/5 15041299 MiSeqDx Cystic Fibrosis 139 Variant Assay Box 5/5
ILLUMINA, INC.
15036580
Not in Commercial Distribution

  • 00816270020019 ()
DX-102-1004

  • Cystic fibrosis IVD, kit, multiplex
No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.5
In Commercial Distribution

  • 00810751030252 ()


  • X-ray system computer, diagnostic, general-purpose
No Description
C.M.T. MEDICAL TECHNOLOGIES LTD.
63627589
In Commercial Distribution

  • 07290012104909 ()


  • Stationary general-purpose fluoroscopic x-ray system, digital
Healgen (DrugConfirm) - 10 Panel Cup Test: AMP1000/mAMP1000/BAR300/BZO300/COC300/MTD300/MDMA500/MOP2000/OXY100/PCP25
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP31-6104
In Commercial Distribution

  • 00856464008386 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Benzodiazepine group IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Methadone IVD, reagent
Five Panel Clear Scan Drug Test Cup Drug Combo: AMP | COC | MET | OPI | THC With Adulterants
MERGERS MARKETING, INC.
CSC-254AD
In Commercial Distribution

  • 10850557007857 ()
  • 00850557007850 ()
  • 00850557007843 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Six Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: BZO | COC | MET | OPI | OXY | THC
MERGERS MARKETING, INC.
PS-DOA-564
In Commercial Distribution

  • 10850557007291 ()
  • 00850557007294 ()
  • 00850557007287 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Six Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BZO | COC | MET | OPI | THC
MERGERS MARKETING, INC.
PS-DOA-264
In Commercial Distribution

  • 00850557007164 ()
  • 00850557007171 ()
  • 10850557007178 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel Pre Screen Plus Dip Card (CLIA Waived) Drug Combo: COC | MDMA | MET | OPI | THC
MERGERS MARKETING, INC.
PS-DOA-1554
In Commercial Distribution

  • 10850557007130 ()
  • 00850557007133 ()
  • 00850557007126 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel Pre Screen Plus Dip Card (CLIA Waived) Drug Combo: AMP | COC | OPI | PCP | THC
MERGERS MARKETING, INC.
PS-DOA-154
In Commercial Distribution

  • 00850557007102 ()
  • 00850557007119 ()
  • 10850557007116 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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