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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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HAVAb IgG II Controls
Abbott GmbH
06S9310
In Commercial Distribution

  • 00380740197643 ()
06S9310

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, control
HAVAb IgG II Calibrator
Abbott GmbH
06S9301
In Commercial Distribution

  • 00380740197636 ()
06S9301

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, calibrator
Immunoglobulin A
Abbott GmbH
9D98-22
Not in Commercial Distribution

  • 00380740175177 ()
09D9822

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
Quantia ASO Calibrator
ABBOTT LABORATORIES
6K46-02
In Commercial Distribution

  • 00380740030056 ()
06K4602

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator
Immunoglobulin A
ABBOTT LABORATORIES
9D98-21
In Commercial Distribution

  • 00380740019754 ()
09D9821

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
ARCHITECT HAVAB-G Controls
Abbott GmbH
6L27-10
In Commercial Distribution

  • 00380740011178 ()
06L2710

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, control
ARCHITECT HAVAB-G Calibrator
Abbott GmbH
6L27-01
In Commercial Distribution

  • 00380740011161 ()
06L2701

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, calibrator
Alinity i HAVAb IgG Calibrator
Abbott GmbH
08P2701
In Commercial Distribution

  • 00380740131357 ()
08P2701

  • Hepatitis A virus immunoglobulin G (IgG) antibody IVD, calibrator
No Description
ALERE NORTH AMERICA, LLC
46050
In Commercial Distribution

  • 10859035006221 ()
  • 00859035006224 ()


  • Beta-haemolytic Group A Streptococcus total antibody IVD, kit, agglutination
No Description
ALERE NORTH AMERICA, LLC
47050
In Commercial Distribution

  • 10859035006214 ()
  • 00859035006217 ()


  • Beta-haemolytic Group A Streptococcus total antibody IVD, kit, agglutination
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