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
CEPHEID
INFINITY 80-72
Not in Commercial Distribution

  • 07332940003975 ()
900-0502

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
CEPHEID
INFINITY 80-80
Not in Commercial Distribution

  • 07332940003968 ()
900-0503

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

  • 07332940003951 ()
900-0505R

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

  • 07332940003937 ()
900-0510R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
CEPHEID
GXIV-2-R
Not in Commercial Distribution

  • 07332940003920 ()
900-0511R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
CEPHEID
GXIV-3-R
Not in Commercial Distribution

  • 07332940003913 ()
900-0512R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
CEPHEID
GXIV-4-R
Not in Commercial Distribution

  • 07332940003890 ()
900-0513R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
CEPHEID
GXII-2-R
Not in Commercial Distribution

  • 07332940003852 ()
900-0485R

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
CEPHEID
INFINITY 80-16
Not in Commercial Distribution

  • 07332940003838 ()
900-0495

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
CEPHEID
INFINITY 80-24
Not in Commercial Distribution

  • 07332940003821 ()
900-0496

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
CEPHEID
INFINITY 80-32
Not in Commercial Distribution

  • 07332940003814 ()
900-0497

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXIV-4
In Commercial Distribution

  • 07332940003449 ()
900-0065

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXIV-4
In Commercial Distribution

  • 07332940003388 ()
900-0138

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXIV-2
In Commercial Distribution

  • 07332940003371 ()
900-0140

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXIV-2
In Commercial Distribution

  • 07332940003364 ()
900-0145

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
XPERT, GENEXPERT DX SYSTEM
CEPHEID
GXIV-1
In Commercial Distribution

  • 07332940003357 ()
900-0146

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Additional catalog numbers: 900-0521-14, 900-0521R
CEPHEID
GXXVI-16
Not in Commercial Distribution

  • 07332940001483 ()
900-0521

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
CEPHEID
GXXVI-12
Not in Commercial Distribution

  • 07332940001476 ()
900-0520

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
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
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