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
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
HWTS-1600S
In Commercial Distribution

  • 06974849369076 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
TargetingOne Technology (Beijing) Corporation
C10 easyPCR System/C10
In Commercial Distribution

  • 06974689626018 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
TargetingOne Technology (Beijing) Corporation
D30 Automatic Digital PCR System /D30
In Commercial Distribution

  • 06974689625189 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
TargetingOne Technology (Beijing) Corporation
D50 Automatic Digital PCR System/D50
In Commercial Distribution

  • 06974689625172 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
TargetingOne Technology (Beijing) Corporation
C6 easyPCR Analyzer/C6
In Commercial Distribution

  • 06974689625165 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
TargetingOne Technology (Beijing) Corporation
C1 easyPCR Analyzer/C1
In Commercial Distribution

  • 06974689625158 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
TargetingOne Technology (Beijing) Corporation
E10 Nucleic Acid Extraction System/E10
In Commercial Distribution

  • 06974689625141 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
TargetingOne Technology (Beijing) Corporation
C0 Thermal Cycler/ C0
In Commercial Distribution

  • 06974689625134 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
TargetingOne Technology (Beijing) Corporation
Chip Reader/ Chip Reader R1
In Commercial Distribution

  • 06974689625103 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
TargetingOne Technology (Beijing) Corporation
Drop Maker/Drop Maker M1
In Commercial Distribution

  • 06974689625097 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
TargetingOne Technology (Beijing) Corporation
Chip Reader/Chip Reader R2
In Commercial Distribution

  • 06974689625080 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
TargetingOne Technology (Beijing) Corporation
Digital PCR analysis System/D2
In Commercial Distribution

  • 06974689624229 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
TargetingOne Technology (Beijing) Corporation
Digital PCR analysis System/D1
In Commercial Distribution

  • 06974689624212 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
TQA-E00182
In Commercial Distribution

  • 06973843220802 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
FQD-96C(EA6)
In Commercial Distribution

  • 06973843220581 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
FQD-96C(EA5)
In Commercial Distribution

  • 06973843220574 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
FQD-96C(EA4)
In Commercial Distribution

  • 06973843220567 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
FQD-96A(EA6)
In Commercial Distribution

  • 06973843220550 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
FQD-96A(EA5)
In Commercial Distribution

  • 06973843220543 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
FQD-96A(EA4)
In Commercial Distribution

  • 06973843220536 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
FQD-96A(EA2)
In Commercial Distribution

  • 06973843220529 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
FQD-16B(EA4)
In Commercial Distribution

  • 06973843220512 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
FQD-16B(EA2)
In Commercial Distribution

  • 06973843220505 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
GE-48DG
In Commercial Distribution

  • 06973843220499 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
GE-96S
In Commercial Distribution

  • 06973843220482 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
GE-48D
In Commercial Distribution

  • 06973843220420 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
GE-4I
In Commercial Distribution

  • 06973843220390 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
GE-384G
In Commercial Distribution

  • 06973843220383 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
GE-48DS
In Commercial Distribution

  • 06973843220376 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For the detail information, please refer to the IFU.
Hangzhou Bioer Technology Co., Ltd.
GE-96G
In Commercial Distribution

  • 06973843220277 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
For qualitative, quantitative, or melting curve analysis of nucleic acid samples derived from research specimens. For research use only.
Sansure Biotech Inc.
96-well, 0.2 mL block
In Commercial Distribution

  • 06955792700864 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The Idylla™ Console is a computer with a vertically oriented touch-screen and a barcode reader placed directly below the touch-screen that communicates with the Idylla™ Instruments. Idylla™ Console and up to eight Idylla™ Instruments constitute the Idylla™ System.
Biocartis NV
Idylla™ Console
In Commercial Distribution

  • 05415219000126 ()
P1010

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Up to eight Idylla™ Instruments and the Idylla™ Console constitute the Idylla™ System.
Biocartis NV
Idylla™ Instrument
In Commercial Distribution

  • 05415219000119 ()
P0010

  • 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
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
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
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
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
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
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
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