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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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EBV IgM Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
6651370C
In Commercial Distribution

  • 00847865002455 ()

  • 1 Each
6651370C

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
MMRV IgG Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002264 ()

  • 1 Each
6652470C

  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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
EBV IgG Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4 V2
In Commercial Distribution

  • 00847865002226 ()

  • 1 Each
6651270C

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Celiac IgA Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_v1
In Commercial Distribution

  • 00847865001250 ()

  • 1 Each
6652370B

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
EBV IgM Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865001236 ()

  • 1 Each
6651370D

  • Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
ARCHITECT UIBC-L Conv Units e-Assay CD ROM
ABBOTT LABORATORIES
4R29-1A
In Commercial Distribution

  • 00380740146672 ()
04R291A

  • Laboratory instrument/analyser application software IVD
ARCHITECT UIBC-L SI Units e-Assay CD ROM
ABBOTT LABORATORIES
4R29-3A
In Commercial Distribution

  • 00380740146689 ()
04R293A

  • Laboratory instrument/analyser application software IVD
BD Horizon CD 138 (MI15) APC-R700 ASR
Becton, Dickinson And Company
663995
In Commercial Distribution

  • 00382906639950 ()
663995

  • CD138 cell marker IVD, antibody
BD Horizon CD 123 (9F5) APC-R700 ASR
Becton, Dickinson And Company
663994
In Commercial Distribution

  • 00382906639943 ()
663994

  • Interleukin-3 receptor (IL-3r) IVD, antibody
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