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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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Celiac IgA Assay Protocol File CD, SW4_v1
BIO-RAD LABORATORIES, INC.
SW4_v1
In Commercial Distribution

  • 00847865010580 ()

  • 1 Each
6652370A

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
Celiac IgG Assay Protocol file CD, SW4_v1
BIO-RAD LABORATORIES, INC.
SW4_v1
In Commercial Distribution

  • 00847865010573 ()

  • 1 Each
6652270A

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
Rubella & CMV Assay Protocol File CD, SW4_v3
BIO-RAD LABORATORIES, INC.
SW4_ V3
Not in Commercial Distribution

  • 00847865003186 ()

  • 1 Each
6653870C

  • Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay
HSV-1 & HSV-2 Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
In Commercial Distribution

  • 00847865002479 ()

  • 1 Each
6653370D

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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
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