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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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No Description
Bioneer Corporation
A-2061
In Commercial Distribution

  • 08809537070751 ()
A-2061

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Bioneer Corporation
A-2060-1
In Commercial Distribution

  • 08809537070034 ()
A-2060-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
KH Medical Co., Ltd.
KM005
In Commercial Distribution

  • 08800204300690 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The RADI CHAMP260 is a stand-alone automated isothermal amplification and detection system for target nucleic acid sequences found in human specimens. The instrument is used in conjunction with KH Medical’s LOOP-Mediated Amplification in vitro diagnostic products. RADI CHAMP260 is designed to freely manipulate specific temperature and running time for amplification of samples by 7 inch touch screen. Amplification of target DNA occurs during the heat cycle and results in the formation of precipitate detected by the RADI CHAMP260 optics system. The precipitate generated by the presence of amplified target DNA leads to a turbid Sample/Control reaction solution which is then measured by absorbance. The RADI CHAMP260 uses the change in turbidity of each Sample/Control reaction solution to report assay results as INVALID, POSITIVE, or NEGATIVE on the 7 inch touch screen.
KH Medical Co., Ltd.
KM002
In Commercial Distribution

  • 08800204300096 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Universal IPPB Circuit
TELEFLEX INCORPORATED
IPN913682
In Commercial Distribution

  • 24026704645767 ()
  • 14026704645760 ()
1560

  • Ventilator breathing circuit, single-use
BD Viper™ SDA Extraction Reagent Trough
BECTON, DICKINSON AND COMPANY
441994
In Commercial Distribution

  • 30382904419944 ()
  • 00382904419943 ()
441994

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper Neutralization Pouch
BECTON, DICKINSON AND COMPANY
441354
In Commercial Distribution

  • 30382904413546 ()
  • 00382904413545 ()
441354

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper™ LT System PCR Accessory kit
BECTON, DICKINSON AND COMPANY
442967
In Commercial Distribution

  • 00382904429676 ()
442967

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper™ LT System SDA Accessory Kit
BECTON, DICKINSON AND COMPANY
442958
In Commercial Distribution

  • 00382904429584 ()
442958

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper™ LT System PCR Tube/Tray Kit
BECTON, DICKINSON AND COMPANY
442957
In Commercial Distribution

  • 00382904429577 ()
442957

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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