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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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No Description
DIASORIN SPA
P001932
In Commercial Distribution

  • 08056771102377 ()


  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
Alinity s HBsAg Calibrator Kit
Abbott Ireland Diagnostics
06P0204
In Commercial Distribution

  • 00380740136772 ()
06P0204

  • Hepatitis B virus surface antigen IVD, calibrator
Alinity i HAVAb IgG Controls
Abbott GmbH
08P2710
In Commercial Distribution

  • 00380740131364 ()
08P2710

  • Hepatitis B virus core antigen IVD, calibrator
No Description
DIASORIN SPA
N0143
In Commercial Distribution

  • E125N014308 ()


  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
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
VIROTROL IV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00111
In Commercial Distribution

  • 00847661002611 ()
00111

  • Hepatitis B virus e-antigen total antibody IVD, control
aHBs2 - Atellica IM - Master Curve Material Kit 5 x 1 x 1.0mL
Siemens Healthcare Diagnostics Inc.
10995667
In Commercial Distribution

  • 00630414600512 ()
10995667

  • Hepatitis B virus surface total antibody IVD, control
aHBs2 Master Curve Material
Siemens Healthcare Diagnostics Inc.
10285962
In Commercial Distribution

  • 00630414555300 ()
4800387

  • Hepatitis B virus surface total antibody IVD, control
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