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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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Hologic - 15420045506572

Universal General Purpose Reagent - Universal Arm1/Red FRET.
Hologic, Inc.
UNIVERSAL ARM1/RED FRET
In Commercial Distribution

  • 15420045506572 ()
96-008

  • Nucleic acid technique (NAT) chemiluminescent signal generation kit IVD

Vysis - 00884999031647

Vysis LSI BCR/ABL1/ASS1 Tri-Color Dual Fusion Probe (20 uL)
ABBOTT MOLECULAR INC.
08L79-020
In Commercial Distribution

  • 00884999031647 ()
08L79-020

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999029392

Vysis LSI MYB (6q23) SpectrumOrange Probe
ABBOTT MOLECULAR INC.
07J86-011
In Commercial Distribution

  • 00884999029392 ()
07J86-011

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999029156

Vysis LSI N-MYC SpectrumGreen/CEP 2 SpectrumOrange Probe
ABBOTT MOLECULAR INC.
07J72-001
In Commercial Distribution

  • 00884999029156 ()
07J72-001

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999027091

Vysis CEP X SpectrumOrange/ Y SpectrumGreen
ABBOTT MOLECULAR INC.
07J22-050
In Commercial Distribution

  • 00884999027091 ()
07J22-050

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027084

CEP 12 SpectrumOrange
ABBOTT MOLECULAR INC.
07J22-012
In Commercial Distribution

  • 00884999027084 ()
07J22-012

  • Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe

Vysis - 00884999027077

CEP 8 SpectrumOrange
ABBOTT MOLECULAR INC.
07J22-008
In Commercial Distribution

  • 00884999027077 ()
07J22-008

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027060

ProbeChek Low Level Male 95% XX/5% XY
ABBOTT MOLECULAR INC.
07J21-012
In Commercial Distribution

  • 00884999027060 ()
07J21-012

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027053

ProbeChek Low Level Female 5% XX/95% XY
ABBOTT MOLECULAR INC.
07J21-011
In Commercial Distribution

  • 00884999027053 ()
07J21-011

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027046

ProbeChek Positive Control 10% Trisomy 8/12
ABBOTT MOLECULAR INC.
07J21-002
In Commercial Distribution

  • 00884999027046 ()
07J21-002

  • Cancer/tumour-associated aneuploidy IVD, probe
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