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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 - 00884999002715

Vysis LSI ERBB2 (17q12) SpectrumGreen Probe
ABBOTT MOLECULAR INC.
02N20-020
In Commercial Distribution

  • 00884999002715 ()
02N20-020

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999002708

Vysis LSI MAPT 17q21 SpectrumGreen Probe
ABBOTT MOLECULAR INC.
02N19-010
In Commercial Distribution

  • 00884999002708 ()
02N19-010

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999002623

Vysis LSI MYC (8q24) SpectrumRed Probe
ABBOTT MOLECULAR INC.
02N12-030
In Commercial Distribution

  • 00884999002623 ()
02N12-030

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999002609

Vysis LSI TERC (3q26) SpectrumGold Probe
ABBOTT MOLECULAR INC.
02N11-030
In Commercial Distribution

  • 00884999002609 ()
02N11-030

  • Nucleic acid hybridization detection IVD, probe

UroVysion - 00884999002180

UroVysion Bladder Cancer Kit
ABBOTT MOLECULAR INC.
02J27-095
In Commercial Distribution

  • 00884999002180 ()
02J27-095

  • Bladder tumour-associated mutation IVD, probe

UroVysion - 00884999002142

UroVysion Bladder Cancer Kit
ABBOTT MOLECULAR INC.
02J27-025
In Commercial Distribution

  • 00884999002142 ()
02J27-025

  • Bladder tumour-associated mutation IVD, probe

UroVysion - 00884999002128

ProbeChek UroVysion Bladder Cancer Kit Control Slides
ABBOTT MOLECULAR INC.
02J27-011
In Commercial Distribution

  • 00884999002128 ()
02J27-011

  • Bladder tumour-associated mutation IVD, control

PathVysion - 00884999001763

PathVysion HER-2 DNA Probe Kit
ABBOTT MOLECULAR INC.
02J01-036
In Commercial Distribution

  • 00884999001763 ()
02J01-036

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, reagent

PathVysion - 00884999001756

PathVysion HER-2 DNA Probe Kit
ABBOTT MOLECULAR INC.
02J01-035
In Commercial Distribution

  • 00884999001756 ()
02J01-035

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, reagent

PathVysion - 00884999001732

PathVysion HER-2 DNA Probe Kit
ABBOTT MOLECULAR INC.
02J01-030
In Commercial Distribution

  • 00884999001732 ()
02J01-030

  • Human epidermal growth factor receptor 2 (HER2) protein IVD, reagent
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