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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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Lyme B. burgdorferi (IgM) Marstripe Test
IMMCO DIAGNOSTICS, INC.
6101M
In Commercial Distribution

  • 00845714004834 ()

  • 20 determinations
6101M

  • Multiple clinical chemistry protein IVD, kit, immunoblot
Lyme B. burgdorferi (IgG) Marstripe Test
IMMCO DIAGNOSTICS, INC.
6101G
In Commercial Distribution

  • 00845714004711 ()

  • 20 determinations
6101G

  • Multiple clinical chemistry protein IVD, kit, immunoblot
EDWARDS COMMANDER DELIVERY SYSTEM
Edwards Lifesciences LLC
9600LDS20
In Commercial Distribution

  • 00690103193930 ()

  • 20 MM
9600LDS20A

  • Pulmonary transcatheter heart valve bioprosthesis
  • Aortic transcatheter heart valve bioprosthesis, stent-like framework
HER2 CISH pharmDx Kit
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
SK109
In Commercial Distribution

  • 05700572032960 ()

  • 20 Tests


  • HER2/neu/erbB2 mRNA expression IVD, kit, nucleic acid technique (NAT)
HER2 IQFISH pharmDx™
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
K5731
In Commercial Distribution

  • 05700572032465 ()

  • 20 Tests


  • HER2/neu/erbB2 mRNA expression IVD, kit, nucleic acid technique (NAT)
SureFISH 8q13.3 NCOA2 5' BA 258kb P20 RD
AGILENT TECHNOLOGIES, INC.
G110222R
Not in Commercial Distribution

  • 05700574031336 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH 9p21.3 CDKN2A 57kb P20 RD
AGILENT TECHNOLOGIES, INC.
G110221R
In Commercial Distribution

  • 05700574031329 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH 7p12.2 IKZF1 62kb P20 RD
AGILENT TECHNOLOGIES, INC.
G110220R
In Commercial Distribution

  • 05700574031312 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH 8p12 NRG1 5' BA 460kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110219G
In Commercial Distribution

  • 05700574031305 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH 8p12 NRG1 3' BA 248kb P20 RD
AGILENT TECHNOLOGIES, INC.
G110218R
In Commercial Distribution

  • 05700574031299 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH 1p36.23 CAMTA1 647kb P20 RD
AGILENT TECHNOLOGIES, INC.
G110216R
In Commercial Distribution

  • 05700574031275 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH NTRK1 3' 140kb P20 RD
AGILENT TECHNOLOGIES, INC.
G110214R
In Commercial Distribution

  • 05700574031251 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH 11q13.3 CCND1 997kb P20 RD
AGILENT TECHNOLOGIES, INC.
G110212R
In Commercial Distribution

  • 05700574031237 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH 5p15.33 TERT 1107kb P20 RD
AGILENT TECHNOLOGIES, INC.
G110210R
Not in Commercial Distribution

  • 05700574031213 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH TGFBR3 3' BA 402kb P20 RD
AGILENT TECHNOLOGIES, INC.
G110207R
In Commercial Distribution

  • 05700574031183 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH PAX3 5' BA 285Kb P20 RD
AGILENT TECHNOLOGIES, INC.
G110205R
In Commercial Distribution

  • 05700574031169 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH CIC 3' BA 239kb P20 RD
AGILENT TECHNOLOGIES, INC.
G110203R
In Commercial Distribution

  • 05700574031145 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH JAK2 3' BA 503kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110201G
In Commercial Distribution

  • 05700574031121 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH Chr7 CEP 767kb P20 BL
AGILENT TECHNOLOGIES, INC.
G110899B
In Commercial Distribution

  • 05700574031107 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH 19p13.2 ZNF443 513kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110897G
In Commercial Distribution

  • 05700574031084 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH 8q24.3 Chr8qTel 397kb P20 BL
AGILENT TECHNOLOGIES, INC.
G110897B
Not in Commercial Distribution

  • 05700574031077 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH 8p23.3 Chr8pTel 406kb P20 BL
AGILENT TECHNOLOGIES, INC.
G110896B
Not in Commercial Distribution

  • 05700574031060 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH 7p22.3 Chr7pTel 426kb P20 BL
AGILENT TECHNOLOGIES, INC.
G110895B
Not in Commercial Distribution

  • 05700574031053 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH 6q27 Chr6qTel 390kb P20 BL
AGILENT TECHNOLOGIES, INC.
G110894B
Not in Commercial Distribution

  • 05700574031046 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH 5q35.3 Chr5qTel 397kb P20 BL
AGILENT TECHNOLOGIES, INC.
G110892B
Not in Commercial Distribution

  • 05700574031039 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH 5p15.33 Chr5pTel 403kb P20 BL
AGILENT TECHNOLOGIES, INC.
G110891B
Not in Commercial Distribution

  • 05700574031015 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH Chr12 CEP 704kb P20 BL
AGILENT TECHNOLOGIES, INC.
G110890B
In Commercial Distribution

  • 05700574030995 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH Chr2 CEP 448kb P20 BL
AGILENT TECHNOLOGIES, INC.
G110889B
In Commercial Distribution

  • 05700574030971 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH Chr22 CEP 668kb P20 GR
AGILENT TECHNOLOGIES, INC.
G110888G
In Commercial Distribution

  • 05700574030964 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
SureFISH Chr22 CEP 668kb P20 BL
AGILENT TECHNOLOGIES, INC.
G110888B
In Commercial Distribution

  • 05700574030957 ()

  • 20 µl


  • Nucleic acid hybridization detection IVD, reagent
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