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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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Elecsys Anti-HBc II - 07613336183106

No Description
Roche Diagnostics GmbH
09014926162
In Commercial Distribution

  • 07613336228487 ()
  • 07613336183106 ()
09014926162

  • Hepatitis B virus core antigen IVD, kit, chemiluminescent immunoassay

Elecsys HBsAg II - 07613336183076

No Description
Roche Diagnostics GmbH
08814848162
In Commercial Distribution

  • 07613336228456 ()
  • 07613336183076 ()
08814848162

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

D3 Ultra - 30014613330417

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

D3 - 30014613330400

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

Acrometrix GBS Positive Control - 00884883006386

No Description
Microgenics Corporation
960041
Not in Commercial Distribution

  • 00884883006386 ()


  • Beta-haemolytic Group B Streptococcus antigen IVD, control

Novocastra™ - 05055331316875

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

Alinity - 00380740136772

Alinity s HBsAg Calibrator Kit
Abbott Ireland Diagnostics
06P0204
In Commercial Distribution

  • 00380740136772 ()
06P0204

  • Hepatitis B virus surface antigen IVD, calibrator

Alinity - 00380740131364

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

  • 00380740131364 ()
08P2710

  • Hepatitis B virus core antigen IVD, calibrator

ETI-MAK-2 PLUS - 08056771102377

No Description
DIASORIN SPA
P001932
In Commercial Distribution

  • 08056771102377 ()


  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)

HBsAg Confirmatory Test - E125N014308

No Description
DIASORIN SPA
N0143
In Commercial Distribution

  • E125N014308 ()


  • Hepatitis B virus surface antigen IVD, kit, enzyme immunoassay (EIA)
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