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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 - 05055844905924

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

USA-LPH024

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

Cytocell Aquarius - 05055844901605

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

  • 05055844901605 ()
USA-LPH017

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

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 - 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 - 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 - 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 - 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
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