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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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BioPlex 2200 - 00847865010573

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

BioPlex 2200 - 00847865002295

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

BioPlex 2200 - 00847865002288

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

BioPlex 2200 - 00847865000857

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

BioPlex 2200 - 00847865000840

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

BioPlex 2200 - 00847865000833

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

BioPlex 2200 - 00847865000826

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

BioPlex 2200 - 00847865000819

Anti-CCP Calibrator Set
BIO-RAD LABORATORIES, INC.
6633200
In Commercial Distribution

  • 00847865000819 ()

  • Total Volume: 0.5 Milliliter
  • 6 Vials
6633200

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

Autoimmune EIA - 00847817018343

Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgG
BIO-RAD LABORATORIES, INC.
425-2280
In Commercial Distribution

  • 00847817018343 ()

  • 96 Tests
4252280

  • Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)

M SERIES BIPHASIC - 00847946002817

Defibrillator ,MAIN,HOSPITAL PRIMARY, 3/5LEAD,AC,BIPHASIC,LCD,RCD,SMR,ENG
Zoll Medical Corporation
40010011100010011
In Commercial Distribution

  • 00847946002817 ()

  • 6.8" x 10.3" x 8.2"


  • Physiologic-monitoring defibrillation system
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