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
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
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A50745
In Commercial Distribution

  • 10190302016148 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
A47324
In Commercial Distribution

  • 10190302015592 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
ION ONE TOUCH ES DX INST
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
ONE TOUCH ES DX
In Commercial Distribution

  • 10190302000864 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
ION ONE TOUCH DX INST
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
ONE TOUCH DX
In Commercial Distribution

  • 10190302000857 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
LAMP,HALOGEN RC, IVD
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
4480914
In Commercial Distribution

  • 10190302000734 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
8788
In Commercial Distribution

  • 10190302000697 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
VERITI DX 384W THERMAL CYCLER
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
9913
In Commercial Distribution

  • 10190302000536 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
9912
In Commercial Distribution

  • 10190302000529 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
VERITI DX 96W FAST THERM CYCLR
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
9911
In Commercial Distribution

  • 10190302000512 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
7503
In Commercial Distribution

  • 10190302000222 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
DIASORIN MOLECULAR LLC
MOL1011-P
In Commercial Distribution

  • 10816101025036 ()
MOL1011-P

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
DIASORIN MOLECULAR LLC
MOL1011
In Commercial Distribution

  • 10816101025029 ()
MOL1011

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
DIASORIN MOLECULAR LLC
MOL1001-P
In Commercial Distribution

  • 10816101025012 ()
MOL1001-P

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
DIASORIN MOLECULAR LLC
MOL1001
In Commercial Distribution

  • 10816101025005 ()
MOL1001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
NeuMoDx™ 96 Molecular System
Neumodx Molecular, Inc.
500200
In Commercial Distribution

  • 00814278020000 ()
  • 10814278020724 ()

  • Width: 137.2 Centimeter
  • Height: 109.2 Centimeter
  • Depth: 109.2 Centimeter
500200

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
NeuMoDx™ 288 Molecular System
Neumodx Molecular, Inc.
500100
In Commercial Distribution

  • 00814278020727 ()
  • 10814278020014 ()

  • Depth: 109.2 Centimeter
  • Width: 182.9 Centimeter
  • Height: 190.5 Centimeter
500100

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The Revogene® instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The Revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. The Revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real time PCR.
Meridian Bioscience Canada Inc
610210
In Commercial Distribution

  • 00628055344100 ()
610210

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The revogene™ instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. The revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR.
GenePoc Inc
130840
In Commercial Distribution

  • 00628055344001 ()
130840

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD COR GX INSTRUMENT
BECTON, DICKINSON AND COMPANY
443990
In Commercial Distribution

  • 00382904439903 ()
443990

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD COR™ MX
BECTON, DICKINSON AND COMPANY
443989
In Commercial Distribution

  • 00382904439897 ()
443989

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
BD Viper™ System Remanufactured
BECTON, DICKINSON AND COMPANY
442843
Not in Commercial Distribution

  • 00382904428433 ()

  • Height: 79 Inch
  • Width: 75 Inch
  • Depth: 42 Inch
442843

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Instrument Bd Viper LT System
BECTON, DICKINSON AND COMPANY
442839
In Commercial Distribution

  • 00382904428396 ()

  • Width: 51 Inch
  • Height: 46 Inch
  • Depth: 36 Inch
442839

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Instrument Max Clinical Refurb
BECTON, DICKINSON AND COMPANY
441927
In Commercial Distribution

  • 00382904419271 ()

  • Height: 72.4 Centimeter
  • Width: 94 Centimeter
  • Depth: 75.4 Centimeter
441927

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Instrument Max Clinical
BECTON, DICKINSON AND COMPANY
441916
In Commercial Distribution

  • 00382904419165 ()

  • Height: 72.4 Centimeter
  • Width: 94 Centimeter
  • Depth: 75.4 Centimeter
441916

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

  • 01812125010067 ()
AC042

  • 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
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
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
No Description
Roche Molecular Systems, Inc.
03531414001
In Commercial Distribution

  • 08430215046203 ()
03531414001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
DIASORIN SPA
MOL1001
In Commercial Distribution

  • 08056771102872 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
DIASORIN SPA
MOL1011
In Commercial Distribution

  • 08056771102889 ()


  • 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
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