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

  • 00884999027077 ()
07J22-008

  • Cancer/tumour-associated aneuploidy IVD, probe
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
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
ProbeChek Positive Control 10% Trisomy 8/12
ABBOTT MOLECULAR INC.
07J21-002
In Commercial Distribution

  • 00884999027046 ()
07J21-002

  • Cancer/tumour-associated aneuploidy IVD, probe
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 CEP X SpectrumOrange/ Y SpectrumGreen
ABBOTT MOLECULAR INC.
07J20-050
In Commercial Distribution

  • 00884999027022 ()
07J20-050

  • Cancer/tumour-associated aneuploidy IVD, probe
CEP 12 SpectrumOrange
ABBOTT MOLECULAR INC.
07J20-012
In Commercial Distribution

  • 00884999027015 ()
07J20-012

  • Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe
CEP 8 SpectrumOrange
ABBOTT MOLECULAR INC.
07J20-008
In Commercial Distribution

  • 00884999027008 ()
07J20-008

  • Cancer/tumour-associated aneuploidy IVD, probe
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 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 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 CEP 7 (D7Z1) (satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-027
In Commercial Distribution

  • 00884999021853 ()
06J54-027

  • Nucleic acid hybridization detection IVD, probe
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 CEP 11 (D11Z1)(satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-021
In Commercial Distribution

  • 00884999021839 ()
06J54-021

  • Nucleic acid hybridization detection IVD, probe
Vysis CEP 10 (satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-020
In Commercial Distribution

  • 00884999021822 ()
06J54-020

  • Nucleic acid hybridization detection IVD, probe
Vysis CEP 9 (satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-019
In Commercial Distribution

  • 00884999021815 ()
06J54-019

  • Nucleic acid hybridization detection IVD, probe
Vysis CEP 8 (D8Z2)(satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-018
In Commercial Distribution

  • 00884999021808 ()
06J54-018

  • Nucleic acid hybridization detection IVD, probe
Vysis CEP 6 (D6Z1) (satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-016
In Commercial Distribution

  • 00884999021792 ()
06J54-016

  • Nucleic acid hybridization detection IVD, probe
Vysis CEP 4 (satellite) SpectrumAqua Probe
ABBOTT MOLECULAR INC.
06J54-014
In Commercial Distribution

  • 00884999021778 ()
06J54-014

  • Nucleic acid hybridization detection IVD, probe
DAPI II Counterstain, 2 x 500 uL (125ng/mL)
ABBOTT MOLECULAR INC.
06J50-001
In Commercial Distribution

  • 00884999021648 ()
06J50-001

  • DAPI solution IVD
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