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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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Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1V1
In Commercial Distribution

  • 00847865013017 ()

  • 1 Each
6652365A

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1V1
In Commercial Distribution

  • 00847865013000 ()

  • 1 Each
6652365A

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only
BIO-RAD LABORATORIES, INC.
SW4.1_1
In Commercial Distribution

  • 00847865012997 ()

  • 1 Each
6652165B

  • Phospholipid antibody IVD, kit, multiplex
Manual & CDs, APLS IgM IFU, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1V1
In Commercial Distribution

  • 00847865012980 ()

  • 1 Each
6652065B

  • Phospholipid antibody IVD, kit, multiplex
APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only
BIO-RAD LABORATORIES, INC.
SW4.1V1
In Commercial Distribution

  • 00847865012973 ()

  • 1 Each
6651975B

  • Phospholipid antibody IVD, kit, multiplex
Manual & CDs, APLS IgG IFU, SW4.1_v1, US Only
BIO-RAD LABORATORIES, INC.
SW4.1V1
In Commercial Distribution

  • 00847865012966 ()

  • 1 Each
6651965B

  • Phospholipid antibody IVD, kit, multiplex
Manual & CDs, EBV IgG IFU, SW4.1v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865012614 ()

  • 1 Each
6651260F

  • 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
EBV IgG Assay Protocol File CD, SW4.1_v1, US
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865012607 ()

  • 1 Each
6651270D

  • 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
  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Manual & CDs, BioPlex 2200 APLS IgG IFU, SW4_v1, US Only
BIO-RAD LABORATORIES, INC.
SW4_1
In Commercial Distribution

  • 00847865012522 ()

  • 1 Each
6651965A

  • Phospholipid antibody IVD, kit, multiplex
Manual & CDs, APLS IgM IFU, SW4_v1, US Only
BIO-RAD LABORATORIES, INC.
SW4_1
In Commercial Distribution

  • 00847865012515 ()

  • 1 Each
6652065A

  • Phospholipid antibody IVD, kit, multiplex
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