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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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Biomeme Franklin three9 Real-Time PCR Thermocycler - 00810096640024

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

Biomeme Franklin three9 Real-Time PCR Thermocycler - 00810096640017

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

cobas 6800 System - 04015630935406

No Description
Roche Diagnostics GmbH
05524245001
Not in Commercial Distribution

  • 04015630935406 ()
05524245001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

cobas 8800 System - 04015630935390

No Description
Roche Diagnostics GmbH
05412722001
Not in Commercial Distribution

  • 04015630935390 ()
05412722001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

cobas z 480 - 04015630929016

No Description
Roche Molecular Systems, Inc.
05200881001
Not in Commercial Distribution

  • 04015630929016 ()
05200881001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

COBAS® TaqMan® - 04015630925537

No Description
Roche Molecular Systems, Inc.
03121453001
In Commercial Distribution

  • 04015630925537 ()
03121453001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

COBAS®TaqMan® 48 Analyzer - 04015630924745

No Description
Roche Molecular Systems, Inc.
03279332001
In Commercial Distribution

  • 04015630924745 ()
03279332001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

ELITe InGenius® - 03661540900006

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

Opus - 03610522260829

CFX Opus Deepwell Dx
BIO-RAD LABORATORIES, INC.
12016687
In Commercial Distribution

  • 03610522260829 ()

  • 1 ea
12016687

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Opus - 03610522203437

CFX Opus 384 Dx
BIO-RAD LABORATORIES, INC.
12014335
In Commercial Distribution

  • 03610522203437 ()

  • 1 each
12014335

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Opus - 03610522203413

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 - 03610520550984

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 - 03610520457818

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

Revogene® - 00628055344100

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

revogene™ - 00628055344001

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 Viper™ System Remanufactured - 00382904428433

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

BD Viper™ LT System - 00382904428396

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

BD MAX™ System Refurb - 00382904419271

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

BD MAX™ System - 00382904419165

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

QuarkBio® - 04719890680020

Q Station™ Dx 1000
QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)
Q Station
In Commercial Distribution

  • 04719890680020 ()
QST-Dx1000-2

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

QuarkBio® - 04719890680013

Q Station™ Dx 1000
QUARK BIOSCIENCES TAIWAN, INC. (HSINCHU PLANT)
Q Station
In Commercial Distribution

  • 04719890680013 ()
QST-Dx1000-1

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

CHROMA ATE - 04719889100102

The GenXplore® system is an automated qPCR-based nucleic acid testing system. It can perform nucleic acid extraction, liquid handling, thermal cycling, and real-time fluorescence detection for testing nucleic acids from human samples, specifically for in vitro diagnostic purposes. The GenXplore® system is intended for professional use only and indoor use only.
CHROMA ATE INC.
GenXplore q4800
In Commercial Distribution

  • 04719889100102 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

QLoci - 04719880531103

No Description
LIFEOS GENOMICS CORPORATION
md1000 Dx
In Commercial Distribution

  • 04719880531103 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Acuitas - 04260364751017

QuantStudio Real-Time PCR Instrument qualified by Curetis for use with Acuitas AMR Gene Panel.
Curetis GmbH
Curetis Qualified QuantStudio™ 5 Real-Time PCR System
Not in Commercial Distribution

62006

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Unyvero - 04260364750003

Instrument to process 2 Unyvero Cartridges
Curetis GmbH
A50 Analyzer
Not in Commercial Distribution

  • 04260364750003 ()
60001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Accula Flu A / B Control Kit - B540FAB1100CWC0

The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in quality control testing with the Accula™ Flu A / B Test.
MESA BIOTECH, INC.
FAB1100CW-C
In Commercial Distribution

  • B540FAB1100CWC0 ()
FAB1100CW-1

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

Accula Programming Cassette - B540D20010

The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware
MESA BIOTECH, INC.
D2001
In Commercial Distribution

  • B540D20010 ()
D2001

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

Accula Dock - B540D20000

The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette.
MESA BIOTECH, INC.
D2000
In Commercial Distribution

  • B540D20000 ()
D2000

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

Silaris Dock - B54010260

The Silaris Dock is an electronic module which executes in vitro diagnostic tests on compatible Silaris Test Cassettes. It consists of an electro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary to orchestrate in-vitro diagnostic tests within the inserted Test Cassette.
MESA BIOTECH, INC.
1026
In Commercial Distribution

  • B54010260 ()
1026

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

Silaris Influenza A&B Control Kit - B54010240

The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris™ Influenza A&B Test.
MESA BIOTECH, INC.
1024
In Commercial Distribution

  • B54010240 ()
1024

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

Acuitas - 01812125010067

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

iC-Reader - B769ICRADAA00000

The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.
ICUBATE, INC
iCR-ADAA00000
In Commercial Distribution

  • B769ICRADAA00000 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

iC-Processor - B769ICPADAAA0000

The iC-System is an in vitro diagnostic device designed to perform multiplex amplification for the detection and identification of assay-specific targets.
ICUBATE, INC
iCP-ADAAA0000
In Commercial Distribution

  • B769ICPADAAA0000 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Genomadix Cube CYP2C19 - G257ASM000960

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

  • G257ASM000960 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

QIAcuityDx® Four - 04053228048770

The QIAcuityDx® Four is an automated digital PCR (dPCR) instrument designed to perform amplification, detection (qualitative and quantitative), and analysis of nucleic acid samples, isolated from biological specimens. The QIAcuityDx® Four is to be used by trained personnel in a professional laboratory environment.
QIAGEN GmbH
1
In Commercial Distribution

  • 04053228048770 ()
911060

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

QIAstat-Dx Analyzer 2.0 - 04053228047582

The QIAstat-Dx Analyzer 2.0 platform is intended as an in vitro diagnostic device for use with QIAstat-Dx assays and provides full automation from sample preparation to real-time PCR detection for molecular applications.
QIAGEN GmbH
1
In Commercial Distribution

  • 04053228047582 ()
9002828

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

QIAstat-Dx® Analyzer 1.0 - 04053228033936

Additional Catalog Numbers: 9002814 QIAstat-Dx Analytical Module 9002813 QIAstat-Dx Operational Module DI Numbers: QIAstat-Dx Analytical Module DI Number: 04053228033929 QIAstat-Dx Operational Module DI Number: 04053228033936
QIAGEN GmbH
v1
In Commercial Distribution

  • 04053228033936 ()
9002824

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

Rotor-Gene® Q MDx - 04053228010838

No Description
QIAGEN GmbH
1
In Commercial Distribution

  • 04053228010838 ()
9002035

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory

FORCE X - 06971234470447

No Description
Xiamen Weiyou Intelligent Technology Co.,Ltd
CX5
In Commercial Distribution

  • 06971234470447 ()


  • Circulating-fluid localized thermal therapy system

Atom Infant Warmer 103 AC120V - 04942962616331

No Description
ATOM MEDICAL CORPORATION
61633
In Commercial Distribution

  • 04942962616331 ()

  • Depth: 110 Centimeter
  • Width: 84 Centimeter
61633

  • Open infant incubator

BD ProbeTec™ ET Instrument, Remanufactured - 00382904407162

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

ClosureRFS™ - 00643169862999

STYLET RFS2-6-12 CLOSURE FAST V02
MEDTRONIC, INC.
RFS2-6-12
In Commercial Distribution

  • 00643169862999 ()

  • Working Length 12 CM
  • Outer Diameter: 2.0 Millimeter
  • Catheter Gauge: 6.0 French


  • Peripheral vascular electrocautery catheter, single-use

Transcend - M9505030640

No Description
SOMNETICS INTERNATIONAL, INC.
Heated Humidifier
In Commercial Distribution

  • M9505030640 ()

  • Width: 6.625 Inch
  • Length: 12.25 Inch
  • Height: 5.1875 Inch
503064

  • Heated respiratory humidifier

O-Two - 07540195005334

The O-Two single-use electronic ventilator ventilation circuit consists of a single ventilation corrugated hose and equipped with a flow sensor adapter designed to stream the flow without turbulence and create a differential pressure in two points which are connected to differential pressure sensor used to calculate flow. The unique one-way check valve will only allow flow from ventilator to patient and prevent the exhaled flow flowing back to the ventilator. All exhaled flow will be forced out to the atmosphere through the exhausted port of the breathing valve. The 01CV8030 is specifically designed for use with o_two e700, e600 and e500 electronic transport ventilators.
O-Two Medical Technologies Inc
01CV8030
In Commercial Distribution

  • 17540195005331 ()
  • 07540195005334 ()

  • Weight: 260 Gram
  • Length: 6 Feet
01CV8030-CS

  • Ventilator breathing circuit, single-use

R11 Air - 04260489020425

Low level Light System (red light LED and infrared LED) that applies 635nm light and 880nm light for Aesthtic use and for pain indications.
KBL GmbH
R11-s-2848r1-1188i1 UP 12
In Commercial Distribution

  • 04260489020425 ()


  • Red/infrared light phototherapy unit

Migun - B556HY7000UM0

Pain Relief, Multi-function Physiotherapy table, thermal infrared therapeutic heating, Therapeutic manual and electric massage, muscle relaxation, increase circulation.
MIGUN LIFE CO., LTD
HY7000UM
In Commercial Distribution

  • B556HY7000UM0 ()


  • Freestanding electric massager
  • Musculoskeletal infrared phototherapy unit, non-wearable
  • Traction table, line-powered

Pintler Patient Warming System - B389PPWS0011

The Pintler Patient Warming System a thermal regulating reusable operating room pad and a power control unit . The operating room pad utilizes a low voltage heating element and warms patients with conductive warming technology. The system aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired
PINTLER MEDICAL, LLC
PPWS001
In Commercial Distribution

  • B389PPWS0011 ()
PPWS001

  • External electric-heating core temperature regulation system pad
  • External electric-heating core temperature regulation system control unit

Protocol Administration Set with Small Catheter and Retention Cuff - 10815112021280

Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon Insufflation
Bracco Diagnostics Inc.
390402
In Commercial Distribution

  • 30815112021284 ()
  • 10815112021280 ()

  • Catheter Gauge: 20 French
390402

  • Insufflation gas conditioning tubing set

Protocol Touch Administration Set with Small Catheter and Retention Cuff - 10815112021242

Protocol Touch Administration Set w/20 Fr. Tip
Bracco Diagnostics Inc.
390309
In Commercial Distribution

  • 30815112021246 ()
  • 10815112021242 ()

  • Catheter Gauge: 20 French
390309

  • Insufflation gas conditioning tubing set

Protocol Administration Set with Small Catheter and Retention Cuff - 10815112020177

Protocol Administration Set with Small Catheter and Retention Cuff CO2 Delivery System for Colon Insufflation
Bracco Diagnostics Inc.
390402
In Commercial Distribution

  • 30815112020171 ()
  • 10815112020177 ()

  • Catheter Gauge: 20 French
390402

  • Insufflation gas conditioning tubing set
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