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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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Herpes Simplex Type 2 Virus Antigen Substrate, 12 wells, For IFA Test System - B110HS240120

No Description
Bion Enterprises, Ltd.
HS2-4012
In Commercial Distribution

  • B110HS240120 ()
HS2-4012

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG)/IgM antibody IVD, reagent

Herpes Simplex Type 1 Virus Antigen Substrate, 12 wells, For IFA Test System - B110HS130120

No Description
Bion Enterprises, Ltd.
HS1-3012
In Commercial Distribution

  • B110HS130120 ()
HS1-3012

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG)/IgM antibody IVD, reagent

Atellica CH IgM_2 - 00630414595627

Immunoglobulin M ( IgM_2) Atellica CH - RGT 720T
Siemens Healthcare Diagnostics Inc.
11097620
In Commercial Distribution

  • 00630414595627 ()
11097620

  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Atellica CH IgA_2 - 00630414595610

Immunoglobulin A (IgA_2) Atellica CH - RGT 600T
Siemens Healthcare Diagnostics Inc.
11097619
In Commercial Distribution

  • 00630414595610 ()
11097619

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Optilite IgA CSF Kit - 05051700020190

No Description
THE BINDING SITE GROUP LIMITED
LK010.L.OPT.A
In Commercial Distribution

  • 05051700020190 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Optilite IgM CSF Kit - 05051700020183

No Description
THE BINDING SITE GROUP LIMITED
LK012.L.OPT.A
In Commercial Distribution

  • 05051700020183 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry

Optilite IgA Kit - 05051700017701

No Description
THE BINDING SITE GROUP LIMITED
NK010.OPT.A
In Commercial Distribution

  • 05051700017701 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Optilite IgA2 Kit - 05051700017664

No Description
THE BINDING SITE GROUP LIMITED
LK088.OPT.A
In Commercial Distribution

  • 05051700017664 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Optilite IgA1 Kit - 05051700017657

No Description
THE BINDING SITE GROUP LIMITED
NK087.OPT.A
In Commercial Distribution

  • 05051700017657 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, kit, nephelometry/turbidimetry

Optilite IgM Kit - 05051700017565

No Description
THE BINDING SITE GROUP LIMITED
NK012.OPT.A
In Commercial Distribution

  • 05051700017565 ()


  • Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
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