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
CYTOCELL LIMITED
USA-LPH024
In Commercial Distribution

USA-LPH024

  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
  • Myelodysplastic syndrome (MDS) IVD, probe
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
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
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
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
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
SUB Q RECORDER PACK
Cardinal Health 200, LLC
SBAHFSQBMB
In Commercial Distribution

  • 50888439239032 ()
  • 10888439239034 ()
SBAHFSQBMB

  • General surgical procedure kit, medicated
SUB Q RECORDER PACK
Cardinal Health 200, LLC
SBAHFSQBM1
In Commercial Distribution

  • 50888439317549 ()
  • 10888439317541 ()
SBAHFSQBM1

  • General surgical procedure kit, medicated
EYE Q STERILE LABELS
CENTURION MEDICAL PRODUCTS CORPORATION
STL3024
In Commercial Distribution

  • 10653160230205 ()
  • 00653160230208 ()
STL3024

  • Procedural medication labelling set
SUB Q RECORDER PACK
Cardinal Health 200, LLC
SBAHFSQBM2
In Commercial Distribution

  • 50888439403587 ()
  • 10888439403589 ()
SBAHFSQBM2

  • General surgical procedure kit, medicated
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