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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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IGH/CCND1 Translocation, Dual Fusion Probe (ASR)
CYTOCELL LIMITED
LPS031-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
CCND1 Breakapart Probe (ASR)
CYTOCELL LIMITED
LPS030-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
BCL6 Breakapart Probe (ASR)
CYTOCELL LIMITED
LPS029-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
BCL2 Breakapart Probe (ASR)
CYTOCELL LIMITED
LPS028-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
MYC Breakapart Probe (ASR)
CYTOCELL LIMITED
LPS027-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
ROS1 Breakapart Probe (ASR)
CYTOCELL LIMITED
LPS022-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
EML4 Breakapart Probe (ASR)
CYTOCELL LIMITED
LPS020-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
ALK Breakapart Probe (ASR)
CYTOCELL LIMITED
LPS019-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
FGFR1 Breakapart/Amplification Probe (ASR)
CYTOCELL LIMITED
LPS018-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
MALT1 Breakapart Probe (ASR)
CYTOCELL LIMITED
LPS017-A
In Commercial Distribution



  • Assay development analyte-specific reagent IVD
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