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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 - 05055844925250

HER2 Amplification Probe (ASR)
CYTOCELL LIMITED
LPS001-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD

CytoCell - 05055844923904

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



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

CytoCell - 05055844923898

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



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

CytoCell - 05055844923881

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



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

CytoCell - 05055844923874

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



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

CytoCell - 05055844923867

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



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

CytoCell - 05055844923850

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



  • Myelodysplastic syndrome (MDS) IVD, probe

CytoCell - 05055844923843

P53 (TP53) Deletion FISH Probe Kit (IVD (USA))
CYTOCELL LIMITED
USA-LPH017
In Commercial Distribution



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

CytoCell - 05055844923836

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



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

CytoCell - 05055844922600

11cen Probe Green (ASR)
CYTOCELL LIMITED
LPH576-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
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