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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Additional catalog number: 900-0519R
CEPHEID
GXXVI-8
Not in Commercial Distribution

  • 07332940001469 ()
900-0519

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Additional Catalog numbers: 900-0518-1, 900-0518-2, 900-0518-3, 900-0518-6
CEPHEID
GXXVI-4
Not in Commercial Distribution

  • 07332940001452 ()
900-0518

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Additional catalog numbers: 900-0512-HE, 900-0512R
CEPHEID
GXIV-3
Not in Commercial Distribution

  • 07332940001445 ()
900-0512

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Additional catalog numbers: 900-0511-HE, 900-0511R
CEPHEID
GXIV-2
Not in Commercial Distribution

  • 07332940001438 ()
900-0511

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Additional catalog numbers: 900-0510-HE, 900-0510R
CEPHEID
GXIV-1
Not in Commercial Distribution

  • 07332940001421 ()
900-0510

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
CEPHEID
GXII-1
Not in Commercial Distribution

  • 07332940001414 ()
900-0505

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Other Brand Name: GeneXpert Xpress System; Other Version or Model Number: GXIV-CLIA-L Additional catalog numbers: 900-0513-HE, 900-0513R
CEPHEID
GXIV-4
Not in Commercial Distribution

  • 07332940001384 ()
900-0513

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Other Brand Name: GeneXpert Xpress System; Other Version or Model Number: GXII-CLIA-L
CEPHEID
GXII-2
Not in Commercial Distribution

  • 07332940001377 ()
900-0485

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Additional catalog number: 900-0490R
CEPHEID
GXI-1
In Commercial Distribution

  • 07332940001360 ()
900-0490

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4162-16
In Commercial Distribution

  • 06975318150126 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4084-8
In Commercial Distribution

  • 06975318150119 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4082-8
In Commercial Distribution

  • 06975318150102 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4044-4
In Commercial Distribution

  • 06975318150096 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4042-4
In Commercial Distribution

  • 06975318150089 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4164-16
In Commercial Distribution

  • 06975318150072 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4162-16
In Commercial Distribution

  • 06975318150065 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4084-8
In Commercial Distribution

  • 06975318150058 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4082-8
In Commercial Distribution

  • 06975318150041 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4044-4
In Commercial Distribution

  • 06975318150034 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4042-4
In Commercial Distribution

  • 06975318150027 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
ANITOA BIOTECHNOLOGY(HANGZHOU)CO.,LTD.
MQ4164-16
In Commercial Distribution

  • 06975318150010 ()


  • Thermal cycler nucleic acid amplification analyser IVD, point-of-care
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
HWTS-AIO800
In Commercial Distribution

  • 06974849369403 ()
HWTS-EQ055

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
HWTS-1600P
In Commercial Distribution

  • 06974849369083 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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
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