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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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BioPlex 2200 - 00847865002233

Syphilis IgG Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002233 ()

  • 1 Each
6651470D

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865002134

Manual & CDs, BioPlex 2200, Syphilis IgG IFU, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002134 ()

  • 1 Each
6651460E

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865000307

Syphilis IgG Reagent Pack
BIO-RAD LABORATORIES, INC.
6651450
In Commercial Distribution

  • 00847865000307 ()

  • 1 Tests
6651450

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

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

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
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