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



  • Myelodysplastic syndrome (MDS) IVD, probe
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
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
11cen Probe Green (ASR)
CYTOCELL LIMITED
LPH576-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
ATM Probe Red (ASR)
CYTOCELL LIMITED
LPH575-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
IGH Probe Green (ASR)
CYTOCELL LIMITED
LPH568-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
MAF v2 Probe Red (ASR)
CYTOCELL LIMITED
LPH567-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
Chromosome 15 Alpha Satellite Probe Red (ASR)
CYTOCELL LIMITED
LPH548-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
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