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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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Alinity i HAVAb IgG Controls
Abbott GmbH
08P2710
In Commercial Distribution

  • 00380740131364 ()
08P2710

  • Hepatitis B virus core antigen IVD, calibrator
No Description
DIASORIN SPA
P001932
In Commercial Distribution

  • 08056771102377 ()


  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
HBV 1E6 IU/mL Precision
EXACT DIAGNOSTICS, LLC
HBVH202
In Commercial Distribution

  • 00812242030697 ()
HBVH202

  • Hepatitis B virus nucleic acid IVD, calibrator
HBV 1E3 IU/mL Precision
EXACT DIAGNOSTICS, LLC
HBVL201
In Commercial Distribution

  • 00812242030680 ()
HBVL201

  • Hepatitis B virus nucleic acid IVD, calibrator
HBV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HBVP200
In Commercial Distribution

  • 00812242030673 ()
HBVP200

  • Hepatitis B virus nucleic acid IVD, calibrator
HBV Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HBVAMR
In Commercial Distribution

  • 00812242030222 ()
HBVAMR

  • Hepatitis B virus nucleic acid IVD, calibrator
HBV Verification Panel
EXACT DIAGNOSTICS, LLC
HBVP100
In Commercial Distribution

  • 00812242030116 ()
HBVP100

  • Hepatitis B virus nucleic acid IVD, calibrator
Aptima® HBV Quant Assay Calibrator.
Hologic, Inc.
KIT, CALIBRATOR, HBV VL, US IVD
In Commercial Distribution

  • 15420045506756 ()
PRD-03872

  • Hepatitis B virus nucleic acid IVD, calibrator
Alinity m HBV CAL Kit
ABBOTT MOLECULAR INC.
08N47-075
In Commercial Distribution

  • 00884999047808 ()
08N47-075

  • Hepatitis B virus nucleic acid IVD, calibrator
Abbott RealTime HBV Calibrator Kit
ABBOTT MOLECULAR INC.
2N40-70
In Commercial Distribution

  • 00884999003057 ()
2N40-70

  • Hepatitis B virus nucleic acid IVD, calibrator
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