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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
Roche Diagnostics GmbH
08814848162
In Commercial Distribution

  • 07613336228456 ()
  • 07613336183076 ()
08814848162

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
Influenza B DFA Reagent
DIAGNOSTIC HYBRIDS, INC.
01-013202.V2
In Commercial Distribution

  • 30014613330417 ()
01-013202.V2

  • Influenza B virus antigen IVD, kit, fluorescent immunoassay
Influenza B DFA Reagent-BULK
DIAGNOSTIC HYBRIDS, INC.
01-013200.V2-BULK
In Commercial Distribution

  • 30014613330400 ()
01-013200.V2-BULK

  • Influenza B virus antigen IVD, kit, fluorescent immunoassay
NCL-L-Akt-Phos is intended for the qualitative identification by light microscopy of Akt (Phosphorylated) molecules in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
AKT-PHOS-L-CE
Not in Commercial Distribution

  • 05055331316875 ()
NCL-L-AKT-PHOS

  • Protein kinase B IVD, antibody
No Description
Microgenics Corporation
960041
Not in Commercial Distribution

  • 00884883006386 ()


  • Beta-haemolytic Group B Streptococcus antigen IVD, control
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
P001932
In Commercial Distribution

  • 08056771102377 ()


  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN SPA
N0143
In Commercial Distribution

  • E125N014308 ()


  • 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
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
Anti-HBe2 (aHBe2) – ADVIA Centaur – QC Kit
Siemens Healthcare Diagnostics Inc.
10720832
In Commercial Distribution

  • 00630414167947 ()
10720832

  • Hepatitis B virus e-antigen total antibody IVD, control
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