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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 - 00884999036406

Vysis D7S486/CEP 7 FISH Probe Kit
ABBOTT MOLECULAR INC.
04N78-020
In Commercial Distribution

  • 00884999036406 ()
04N78-020

  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe

RealTime - 00884999036147

Abbott RealTime HCV Genotype II Control Kit
ABBOTT MOLECULAR INC.
08L21-80
In Commercial Distribution

  • 00884999036147 ()
08L21-80

  • Hepatitis C virus genotyping IVD, control

RealTime - 00884999036130

Abbott RealTime HCV Genotype II Amplification Reagent Kit
ABBOTT MOLECULAR INC.
08L21-90
In Commercial Distribution

  • 00884999036130 ()
08L21-90

  • Hepatitis C virus genotyping IVD, kit, nucleic acid technique (NAT)

Vysis - 00884999035706

Vysis LSI KIT SpectrumRed Probe
ABBOTT MOLECULAR INC.
06N71-001
In Commercial Distribution

  • 00884999035706 ()
06N71-001

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999035638

Vysis LSI MECOM SpectrumOrange Probe
ABBOTT MOLECULAR INC.
06N62-010
In Commercial Distribution

  • 00884999035638 ()
06N62-010

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999034945

Vysis LSI KRAS SpectrumGold Probe
ABBOTT MOLECULAR INC.
06N70-001
In Commercial Distribution

  • 00884999034945 ()
06N70-001

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999034938

Vysis LSI IGF1R SpectrumRed Probe
ABBOTT MOLECULAR INC.
06N68-001
In Commercial Distribution

  • 00884999034938 ()
06N68-001

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999034921

Vysis RPN1 SpectrumGreen Probes
ABBOTT MOLECULAR INC.
06N61-010
In Commercial Distribution

  • 00884999034921 ()
06N61-010

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999034891

Vysis LSI PIK3CA SpectrumGreen Probe
ABBOTT MOLECULAR INC.
06N10-001
In Commercial Distribution

  • 00884999034891 ()
06N10-001

  • Nucleic acid hybridization detection IVD, probe

Vysis - 00884999031654

Vysis LSI BCR/ABL1/ASS1 Tri-color Dual Fusion Probes (50 uL)
ABBOTT MOLECULAR INC.
08L79-050
In Commercial Distribution

  • 00884999031654 ()
08L79-050

  • Nucleic acid hybridization detection IVD, probe
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