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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 MET SpectrumRed Probe
ABBOTT MOLECULAR INC.
06N05-001
In Commercial Distribution

  • 00884999024977 ()
06N05-001

  • Nucleic acid hybridization detection IVD, probe
Abbott RealTime HIV-1 Amplification Reagent Kit
ABBOTT MOLECULAR INC.
6L18-90
In Commercial Distribution

  • 00884999023949 ()
6L18-90

  • HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
Abbott RealTime HIV-1 Control Kit
ABBOTT MOLECULAR INC.
6L18-80
In Commercial Distribution

  • 00884999023932 ()
6L18-80

  • HIV1 nucleic acid IVD, control
Abbott RealTime HIV-1 Calibrator Kit
ABBOTT MOLECULAR INC.
6L18-70
In Commercial Distribution

  • 00884999023925 ()
6L18-70

  • HIV1 nucleic acid IVD, calibrator
Vysis LSI RUNX1 SpectrumGreen Probe
ABBOTT MOLECULAR INC.
05N98-010
In Commercial Distribution

  • 00884999015500 ()
05N98-010

  • Nucleic acid hybridization detection IVD, probe
Vysis EGR1 FISH Probe Kit
ABBOTT MOLECULAR INC.
04N37-020
In Commercial Distribution

  • 00884999008366 ()
04N37-020

  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
Vysis CLL FISH Probe Kit
ABBOTT MOLECULAR INC.
04N02-020
In Commercial Distribution

  • 00884999007772 ()
04N02-020

  • Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe
Abbott m2000rt Optical Calibration Kit
ABBOTT MOLECULAR INC.
04J71-93
In Commercial Distribution

  • 00884999006577 ()
04J71-93

  • Thermal cycler nucleic acid instrument calibrator/control kit IVD
Abbott RealTime HBV Amplification Reagent Kit
ABBOTT MOLECULAR INC.
2N40-90
In Commercial Distribution

  • 00884999003071 ()
2N40-90

  • Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Abbott RealTime HBV Control Kit
ABBOTT MOLECULAR INC.
2N40-80
In Commercial Distribution

  • 00884999003064 ()
2N40-80

  • Hepatitis B virus nucleic acid IVD, control
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