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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
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
U.S Only IFU, Manual & CDs, Anti-CCP IFU, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1V1
In Commercial Distribution

  • 00847865001366 ()

  • 1 Each
6653265E

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex
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
Anti-CCP Reagent Pack
BIO-RAD LABORATORIES, INC.
6653250
In Commercial Distribution

  • 00847865000857 ()

  • 100 Tests
6653250

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex
Anti-CCP Control Lot Data
BIO-RAD LABORATORIES, INC.
6633240
In Commercial Distribution

  • 00847865000840 ()

  • 1 Each
6633240

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control
Anti-CCP Control Set
BIO-RAD LABORATORIES, INC.
6633230
In Commercial Distribution

  • 00847865000833 ()

  • Total Volume: 1.5 Milliliter
  • 4 Vials
6633230

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, control
CD, BioPlex Anti-CCP Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
6633220
In Commercial Distribution

  • 00847865000826 ()

  • 1 Each
6633220

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