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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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Autoimmune EIA ANA Screening Test
BIO-RAD LABORATORIES, INC.
96AN
In Commercial Distribution

  • 00847817022319 ()

  • 96 Tests
96AN

  • Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA ANA Screening Test
BIO-RAD LABORATORIES, INC.
576AN
In Commercial Distribution

  • 00847817021688 ()

  • 576 Tests
576AN

  • Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)
Kallestad ANCA IFA Ethanol Fixed Slides 5 x 6 Wells
BIO-RAD LABORATORIES, INC.
29416
In Commercial Distribution

  • 00847817020162 ()

  • 5 x 6 Wells
29416

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent
Autoimmune EIA Anti-ß2 Glycoprotein I IgA Test Kit
BIO-RAD LABORATORIES, INC.
425-2100
In Commercial Distribution

  • 00847817018251 ()

  • 96 Tests
425-2100

  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA Anti-?2 Glycoprotein I IgM Test Kit
BIO-RAD LABORATORIES, INC.
425-2080
In Commercial Distribution

  • 00847817018244 ()

  • 96 Tests
425-2080

  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA Anti-ß2 Glycoprotein I IgG Test Kit
BIO-RAD LABORATORIES, INC.
425-2060
In Commercial Distribution

  • 00847817018237 ()

  • 96 Tests
425-2060

  • Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA Anti-Cardiolipin IgA Test Kit
BIO-RAD LABORATORIES, INC.
425-2040
In Commercial Distribution

  • 00847817018220 ()

  • 96 Tests
425-2040

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA Anti-Cardiolipin IgM Test Kit
BIO-RAD LABORATORIES, INC.
425-2020
In Commercial Distribution

  • 00847817018213 ()

  • 96 Tests
425-2020

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Autoimmune EIA Anti-Cardiolipin IgG Test Kit
BIO-RAD LABORATORIES, INC.
425-2000
In Commercial Distribution

  • 00847817018206 ()

  • 96 Tests
425-2000

  • Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA)
Kallestad Anti-Mitochondrial Microplate EIA
BIO-RAD LABORATORIES, INC.
31021
In Commercial Distribution

  • 00847817016257 ()

  • 96 Tests
31021

  • Mitochondrial antibody M2 (anti-Mi2) IVD, kit, enzyme immunoassay (EIA)
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