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

USA-LPH036

  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
  • Myelodysplastic syndrome (MDS) IVD, probe
Del(7q) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH025
In Commercial Distribution

USA-LPH025

  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
  • Myelodysplastic syndrome (MDS) IVD, probe
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
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
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
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
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
Q Screwdriver Guide Tube
K2M, INC.
48110000
In Commercial Distribution

  • 10888857553217 ()
48110000

  • Surgical screwdriver, reusable
Q Pelvic Post Screwdriver
K2M, INC.
48110016
In Commercial Distribution

  • 10888857553101 ()
48110016

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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