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 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

  • 00847865013000 ()

  • 1 Each
6652365A

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
Manual & CDs, Celiac IgA and IgG IFU, SW4_v1
BIO-RAD LABORATORIES, INC.
SW4_1
In Commercial Distribution

  • 00847865011129 ()

  • 1 Each
6652360A

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865010986 ()

  • 1 Each
6653270E

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex
Celiac IgG Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1v1
In Commercial Distribution

  • 00847865010962 ()

  • 1 Each
6652270B

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
Celiac IgG Reagent Pack
BIO-RAD LABORATORIES, INC.
6652250
In Commercial Distribution

  • 00847865010863 ()

  • 100 Tests
6652250

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
Celiac IgA Reagent Pack
BIO-RAD LABORATORIES, INC.
6652350
In Commercial Distribution

  • 00847865010856 ()

  • 100 Tests
6652350

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex
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
U.S. IFU, Manual & CDs, Anti-CCP IFU, SW4_v3
BIO-RAD LABORATORIES, INC.
SW4V3
In Commercial Distribution

  • 00847865002295 ()

  • 1 Each
6653265D

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex
Anti-CCP Assay Protocol File CD, SW4_v3
BIO-RAD LABORATORIES, INC.
SW4_V3
In Commercial Distribution

  • 00847865002288 ()

  • 1 Each
6653270D

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex
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