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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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Vysis - 00884999027039

ProbeChek Negative Control 0% Trisomy 8/12
ABBOTT MOLECULAR INC.
07J21-001
In Commercial Distribution

  • 00884999027039 ()
07J21-001

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027022

Vysis CEP X SpectrumOrange/ Y SpectrumGreen
ABBOTT MOLECULAR INC.
07J20-050
In Commercial Distribution

  • 00884999027022 ()
07J20-050

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999027015

CEP 12 SpectrumOrange
ABBOTT MOLECULAR INC.
07J20-012
In Commercial Distribution

  • 00884999027015 ()
07J20-012

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

Vysis - 00884999027008

CEP 8 SpectrumOrange
ABBOTT MOLECULAR INC.
07J20-008
In Commercial Distribution

  • 00884999027008 ()
07J20-008

  • Cancer/tumour-associated aneuploidy IVD, probe

Vysis - 00884999026254

Propidium Iodide Counterstain, 2 x 500 uL (400 ng/mL)
ABBOTT MOLECULAR INC.
07J06-001
In Commercial Distribution

  • 00884999026254 ()
07J06-001

  • DAPI solution IVD

Vysis - 00884999021990

Vysis LSI/WCP Hybridization Buffer 2 x 500 uL
ABBOTT MOLECULAR INC.
06J67-011
In Commercial Distribution

  • 00884999021990 ()
06J67-011

  • Nucleic acid hybridization detection IVD, reagent

Vysis - 00884999021983

Vysis LSI/WCP Hybridization Buffer 2 x 150 uL
ABBOTT MOLECULAR INC.
06J67-001
In Commercial Distribution

  • 00884999021983 ()
06J67-001

  • Nucleic acid hybridization detection IVD, reagent

Vysis - 00884999021853

Vysis CEP 7 (D7Z1) (satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-027
In Commercial Distribution

  • 00884999021853 ()
06J54-027

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999021846

Vysis CEP 15 (D15Z1)(satellite III) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-025
In Commercial Distribution

  • 00884999021846 ()
06J54-025

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999021839

Vysis CEP 11 (D11Z1)(satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-021
In Commercial Distribution

  • 00884999021839 ()
06J54-021

  • Nucleic acid hybridization detection IVD, probe
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