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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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Blood Grouping Reagent Anti-B (ABO2); Seraclone® Murine Monoclonal (B005); for tube test; 10x10ml
Bio-Rad Medical Diagnostics GmbH
801350100
In Commercial Distribution

  • 07611969950119 ()
801350100

  • Anti-B red blood cell grouping IVD, antibody
HBV LOD
EXACT DIAGNOSTICS, LLC
HBVLOD
In Commercial Distribution

  • 00812242030703 ()
HBVLOD

  • Hepatitis B virus nucleic acid IVD, control
HBV High Run Control
EXACT DIAGNOSTICS, LLC
HBVH102
In Commercial Distribution

  • 00812242030130 ()
HBVH102

  • Hepatitis B virus nucleic acid IVD, control
HBV Low Run Control
EXACT DIAGNOSTICS, LLC
HBVL101
In Commercial Distribution

  • 00812242030123 ()
HBVL101

  • Hepatitis B virus nucleic acid IVD, control
Influenza B Virus Control Stock
DIAGNOSTIC HYBRIDS, INC.
20-4720010
In Commercial Distribution

  • 30014613338529 ()
20-4720010

  • Influenza B virus antigen IVD, control
Blood Grouping Reagent Anti-B (Murine Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems
DIAGAST
27302
In Commercial Distribution

  • 23661562273021 ()
  • 13661562273024 ()
27302

  • Anti-B red blood cell grouping IVD, antibody
Blood Grouping Reagent Anti-B (Murine Monoclonal) formulated for Automated Systems, Beckman Coulter® PK® Systems
DIAGAST
17302
In Commercial Distribution

  • 23661562173024 ()
  • 13661562173027 ()
17302

  • Anti-B red blood cell grouping IVD, antibody
Blood Grouping Reagent, Anti-B (Murine Monoclonal) (9621A8) - This reagent is designed to determine the presence of ABO system blood group antigen B on the surface of human red blood cells by manual tube method.
DIAGAST
210521
In Commercial Distribution

  • 23661562105216 ()
  • 13661562105219 ()
210521

  • Anti-B red blood cell grouping IVD, antibody
Aptima® HBV Quant Assay Controls Kit.
Hologic, Inc.
KIT, CONTROLS, HBV, VL, US IVD
In Commercial Distribution

  • 15420045506763 ()
PRD-03869

  • Hepatitis B virus nucleic acid IVD, control
Alinity m HBV CTRL Kit
ABBOTT MOLECULAR INC.
08N47-085
In Commercial Distribution

  • 00884999047815 ()
08N47-085

  • Hepatitis B virus nucleic acid IVD, control
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