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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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Cytocell Aquarius - 05055844901599

MLL (KMT2A) Breakapart FISH Probe Kit
CYTOCELL LIMITED
USA-LPH013
In Commercial Distribution

  • 05055844901599 ()
USA-LPH013

  • Myelodysplastic syndrome (MDS) IVD, probe
  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe

Cytocell Aquarius - 05055844901582

EVI1 (MECOM) Breakapart FISH Probe Kit
CYTOCELL LIMITED
USA-LPH036
In Commercial Distribution

  • 05055844901582 ()
USA-LPH036

  • Myelodysplastic syndrome (MDS) IVD, probe
  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe

Cytocell Aquarius - 05055844901575

Del(20q) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH020
In Commercial Distribution

  • 05055844901575 ()
USA-LPH020

  • Myelodysplastic syndrome (MDS) IVD, probe

Cytocell Aquarius - 05055844901568

Del(7q) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH025
In Commercial Distribution

  • 05055844901568 ()
USA-LPH025

  • Myelodysplastic syndrome (MDS) IVD, probe
  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe

Cytocell Aquarius - 05055844901551

Del(5q) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH024
In Commercial Distribution

  • 05055844901551 ()
USA-LPH024

  • Myelodysplastic syndrome (MDS) IVD, probe
  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe

Cytocell Aquarius - 05055844901544

CBFβ (CBFB)/MYH11 Translocation, Dual Fusion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH022
In Commercial Distribution

  • 05055844901544 ()
USA-LPH022

  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe

Cytocell Aquarius - 05055844901520

AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH026
In Commercial Distribution

  • 05055844901520 ()
USA-LPH026

  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe

CytoCell - 05055844901476

TFE3 Distal Probe Green
CYTOCELL LIMITED
LPS523-A
In Commercial Distribution

  • 05055844901476 ()


  • Assay development analyte-specific reagent IVD

CytoCell - 05055844901469

TFE3 Proximal Probe Red
CYTOCELL LIMITED
LPS522-A
In Commercial Distribution

  • 05055844901469 ()


  • Assay development analyte-specific reagent IVD

CytoCell - 05055844901452

FOXO1 Distal Probe Red
CYTOCELL LIMITED
LPS519-A
In Commercial Distribution

  • 05055844901452 ()


  • Assay development analyte-specific reagent IVD
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