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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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Vasculitis Control Lot Data
BIO-RAD LABORATORIES, INC.
6631840
In Commercial Distribution

  • 00847865000529 ()

  • 1 Each
6631840

  • Multiple vasculitis-associated antibody IVD, control
Vasculitis Control Set
BIO-RAD LABORATORIES, INC.
6631830
In Commercial Distribution

  • 00847865000512 ()

  • 4 Vials
  • Total Volume: 1.5 Milliliter
6631830

  • Multiple vasculitis-associated antibody IVD, control
Vasculitis Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
6631820
In Commercial Distribution

  • 00847865000505 ()

  • 1 Each
6631820

  • Multiple vasculitis-associated antibody IVD, calibrator
Vasculitis Calibrator Set
BIO-RAD LABORATORIES, INC.
6631800
In Commercial Distribution

  • 00847865000499 ()

  • Total Volume: 0.5 Milliliter
  • 4 Vials
6631800

  • Multiple vasculitis-associated antibody IVD, calibrator
ANA Screen Control Lot Data
BIO-RAD LABORATORIES, INC.
6631141
In Commercial Distribution

  • 00847865000079 ()

  • 1 Each
6631141

  • Multiple antinuclear antibody (ANA) screening IVD, control
ANA Screen Control Set
BIO-RAD LABORATORIES, INC.
6631131
In Commercial Distribution

  • 00847865000055 ()

  • 6 Vials
  • Total Volume: 1.5 Milliliter
6631131

  • Multiple antinuclear antibody (ANA) screening IVD, control
ANA Screen Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
6631121
In Commercial Distribution

  • 00847865000031 ()

  • 1 Each
6631121

  • Multiple antinuclear antibody (ANA) screening IVD, calibrator
ANA Screen Calibrator Set
BIO-RAD LABORATORIES, INC.
6631101
In Commercial Distribution

  • 00847865000017 ()

  • Total Volume: 0.5 Milliliter
  • 7 Vials
6631101

  • Multiple antinuclear antibody (ANA) screening IVD, calibrator
Autoimmune EIA ENA Plus Screening test
BIO-RAD LABORATORIES, INC.
96EP
In Commercial Distribution

  • 00847817022388 ()

  • 96 Tests
96EP

  • Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA)
Kallestad ANCA IFA Formalin Fixed Slides, 5 x 6 Wells
BIO-RAD LABORATORIES, INC.
29418
In Commercial Distribution

  • 00847817022357 ()

  • 5 x 6 Wells
29418

  • Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, reagent
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