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 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
BD ProbeTec™ ET Instrument, Remanufactured
BECTON, DICKINSON AND COMPANY
440716
Not in Commercial Distribution

  • 00382904407162 ()

  • Depth: 28.5 Inch
  • Width: 28.5 Inch
  • Height: 21.5 Inch
440716

  • 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
This contains the laptop, cube, power adapter and cables.
Genomadix Inc
2
In Commercial Distribution

  • G257ASM000960 ()


  • 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
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
BD Viper™ Extraction Reagent and Lysis Trough
BECTON, DICKINSON AND COMPANY
441128
In Commercial Distribution

  • 00382904411282 ()
441128

  • 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
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
The system is a clinical multiplex instrument intended to measure and sort multiple signals generated my multiple probes, intercalating dyes, or other ligands in an assay from a clinical sample. Signals may be generated by fluorescence or other phenomena and may be measured using filters on a photodiode or other detector. It may integrate sample and/or reagent handling, amplification, dedicated instrument control, data acquisition software, raw data storage mechanisms and other essential hardware components along with the signal reader unit. The system is used with specific assays to comprise an assay test system. A real-time thermocycler is intended to identify and/or quantify the presence of specific sequences of double stranded DNA, amplified from a biological source and labeled with fluorescently labeled probes or through the use of intercalating dyes and detect using a high-power light-emitting diode (LED). Fluorescence emission is detected through the use of filters on a photodiode. The emission filters are optimized for use with specific fluorescent dyes.
MERIDIAN BIOSCIENCE, INC.
610210
In Commercial Distribution

  • 00840733102318 ()
610210

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Diagnostics GmbH
05524245001
Not in Commercial Distribution

  • 04015630935406 ()
05524245001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Diagnostics GmbH
05412722001
Not in Commercial Distribution

  • 04015630935390 ()
05412722001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
05200881001
Not in Commercial Distribution

  • 04015630929016 ()
05200881001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
03121453001
In Commercial Distribution

  • 04015630925537 ()
03121453001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Roche Molecular Systems, Inc.
03279332001
In Commercial Distribution

  • 04015630924745 ()
03279332001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The ELITe InGenius® system is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests. The ELITe InGenius system is a fully automated device integrating extraction and purification of nucleic acids from multiple sample types, amplification and detection of the target sequence by real-time Polymerase Chain Reaction (PCR), and result interpretation. ELITe InGenius® is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay
ELITECHGROUP SPA
INT030-K
In Commercial Distribution

  • 03661540900006 ()
INT030-K

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX Opus Deepwell Dx
BIO-RAD LABORATORIES, INC.
12016687
In Commercial Distribution

  • 03610522260829 ()

  • 1 ea
12016687

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX Opus 384 Dx
BIO-RAD LABORATORIES, INC.
12014335
In Commercial Distribution

  • 03610522203437 ()

  • 1 each
12014335

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX Opus 96 Dx
BIO-RAD LABORATORIES, INC.
12014330
In Commercial Distribution

  • 03610522203413 ()

  • 1 each
12014330

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX96 Dx and CFX96 Deep Well Dx Systems
BIO-RAD LABORATORIES, INC.
1844095-IVD
In Commercial Distribution

  • 03610520550984 ()
1844095-IVD

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
CFX96 Dx and CFX96 Deep Well Dx Systems
BIO-RAD LABORATORIES, INC.
1845097-IVD
In Commercial Distribution

  • 03610520457818 ()
1845097-IVD

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
GENEXPERT Xpress System
CEPHEID
GX-IV Xpress
In Commercial Distribution

  • 07332940009243 ()
GX-IV Xpress

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
CEPHEID
GX-INFINITY 80
In Commercial Distribution

  • 07332940007720 ()
GX-INFINITY 80

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80
CEPHEID
GX-INFINITY 48S
In Commercial Distribution

  • 07332940007713 ()
GX-INFINITY 48S

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GX-XVI R2
In Commercial Distribution

  • 07332940007706 ()
GX-XVI R2

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GX-IV R2
In Commercial Distribution

  • 07332940007690 ()
GX-IV R2

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GX-II R2
In Commercial Distribution

  • 07332940007683 ()
GX-II R2

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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