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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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Automated PCR analyzer
DXNA LLC
91004001
In Commercial Distribution

  • A91004001 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD PCR Cartridges 24EA
BECTON, DICKINSON AND COMPANY
437519
In Commercial Distribution

  • 30382904375196 ()
  • 00382904375195 ()
437519

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Savanna Instrument
DIAGNOSTIC HYBRIDS, INC.
20382R
In Commercial Distribution

  • 30014613340089 ()
20382R

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
Savanna Instrument
DIAGNOSTIC HYBRIDS, INC.
20382
In Commercial Distribution

  • 30014613339304 ()
20382

  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.
Opgen, Inc.
AC042
Not in Commercial Distribution

  • 20812125010062 ()
AC042

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Zhuhai Shineway Biotech Co.,Ltd
SWSI-02
In Commercial Distribution

  • 16974900600091 ()
  • 26974900600104 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Zhuhai Shineway Biotech Co.,Ltd
SWM-02
In Commercial Distribution

  • 16974900600039 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. White color
Biomeme, Inc.
2.8
In Commercial Distribution

  • 00810096640123 ()
1000018

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. Black color
Biomeme, Inc.
2.8
In Commercial Distribution

  • 00810096640116 ()
1000003

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells. White color
Biomeme, Inc.
2.9
In Commercial Distribution

  • 00810096640024 ()
1000018

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Portable, battery-operated real-time PCR and isothermal analysis thermocycler capable of detecting up to three pre-determined wavelengths per well for triplex reactions, with a total of 9 wells.
Biomeme, Inc.
2.9
In Commercial Distribution

  • 00810096640017 ()
1000003

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Alinity m System
ABBOTT MOLECULAR INC.
08N53-002
In Commercial Distribution

  • 00884999048034 ()
08N53-002

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
m2000rt Instrument System
ABBOTT MOLECULAR INC.
9K15-01
In Commercial Distribution

  • 00884999031814 ()
9K15-01

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
07402759190
In Commercial Distribution

  • 00875197005660 ()
07402759190

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
FilmArray Commercial Laptop for use with the BIOFIRE FILMARRAY 2.0 instrument
BIOFIRE DEFENSE, LLC
COMP-SUB-0034
In Commercial Distribution

  • 00851458005297 ()
COMP-SUB-0034

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
NGDS FilmArray Configuration kit (no computer included).
BIOFIRE DEFENSE, LLC
NGDS-ASY-0004
In Commercial Distribution

  • 00851458005143 ()
NGDS-ASY-0004

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Refurbished IVD Instrument NGDS Configuration.
BIOFIRE DEFENSE, LLC
NGDS-ASY-0002
In Commercial Distribution

  • 00851458005129 ()
NGDS-ASY-0002U

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
NGDS FilmArray Instrument
BIOFIRE DEFENSE, LLC
1.5
Not in Commercial Distribution

  • 00851458005112 ()
FLM1-ASY-0121

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
IVD Instrument NGDS Configuration.
BIOFIRE DEFENSE, LLC
NGDS-ASY-0002
In Commercial Distribution

  • 00851458005051 ()
NGDS-ASY-0002

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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
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
No Description
OPTOLANE Technologies Inc.
LOAA Analyzer
In Commercial Distribution

  • 08809740940025 ()
LAM301-01

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Bioneer Corporation
A-2065-4
In Commercial Distribution

  • 08809537078443 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Bioneer Corporation
A-2065-3
In Commercial Distribution

  • 08809537078436 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Bioneer Corporation
A-2065-2
In Commercial Distribution

  • 08809537078429 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Bioneer Corporation
A-2065-1
In Commercial Distribution

  • 08809537078412 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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
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