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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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DASH® Rapid PCR Instrument - 00850063063005

The DASH® Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chain reaction (RT-PCR) instrument that extracts specimens and performs nucleic acid amplified tests (NAAT) in DASH test cartridges for the qualitative detection of infectious diseases. The DASH Instrument is intended for use in conjunction with DASH Rapid PCR System tests to aid in the diagnosis of infectious diseases.
Nuclein, LLC
DASH-0002
In Commercial Distribution

  • 00850063063005 ()
SG-0002

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care

Fluxergy Analyzer - 00850027856124

No Description
Fluxergy, Inc.
Mk12.1
In Commercial Distribution

  • 00850027856124 ()
5506-CE

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care

LOAA - 08809740940025

No Description
OPTOLANE Technologies Inc.
LOAA Analyzer
In Commercial Distribution

  • 08809740940025 ()
LAM301-01

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Exicycler™ V5 384 Fast - 08809537078443

No Description
Bioneer Corporation
A-2065-4
In Commercial Distribution

  • 08809537078443 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Exicycler™ V5 384 - 08809537078436

No Description
Bioneer Corporation
A-2065-3
In Commercial Distribution

  • 08809537078436 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Exicycler™ V5 96 Fast - 08809537078429

No Description
Bioneer Corporation
A-2065-2
In Commercial Distribution

  • 08809537078429 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Exicycler™ V5 96 - 08809537078412

No Description
Bioneer Corporation
A-2065-1
In Commercial Distribution

  • 08809537078412 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Exicycler™ 384 - 08809537070751

No Description
Bioneer Corporation
A-2061
In Commercial Distribution

  • 08809537070751 ()
A-2061

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Exicycler™ 96 - 08809537070034

No Description
Bioneer Corporation
A-2060-1
In Commercial Distribution

  • 08809537070034 ()
A-2060-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

RADI PCR 96 Plus - 08800204300690

No Description
KH Medical Co., Ltd.
KM005
In Commercial Distribution

  • 08800204300690 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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