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

  • 00850027856124 ()
5506-CE

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A55826
In Commercial Distribution

  • 10190302018944 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES CORPORATION
A54626
In Commercial Distribution

  • 10190302018449 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES CORPORATION
A52649, V2.0.0
In Commercial Distribution

  • 10190302018159 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES CORPORATION
A52015, V1.0.5
In Commercial Distribution

  • 10190302017862 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A51222
In Commercial Distribution

  • 10190302017336 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A51220
In Commercial Distribution

  • 10190302017329 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A51197
In Commercial Distribution

  • 10190302016162 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A51195
In Commercial Distribution

  • 10190302016155 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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