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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
ALERE NORTH AMERICA, LLC
47050
In Commercial Distribution

  • 10859035006214 ()
  • 00859035006217 ()


  • Beta-haemolytic Group A Streptococcus total antibody IVD, kit, agglutination
VITROS Chemistry Products Calibrator Kit 28
ORTHO-CLINICAL DIAGNOSTICS, INC.
6802323
In Commercial Distribution

  • 10758750002597 ()
6802323

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator
VITROS Immunodiagnostic Products Anti-HAV IgM Controls
ORTHO CLINICAL DIAGNOSTICS
6800835
In Commercial Distribution

  • 10758750000883 ()
  • 20758750000880 ()
6800835

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control
No Description
HORIBA ABX SAS
1300023881
In Commercial Distribution

  • 03610230007334 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
No Description
Ventana Medical Systems, Inc.
05267927001
In Commercial Distribution

  • 04015630971503 ()
05267927001

  • Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD
No Description
Roche Diagnostics GmbH
3507343190
In Commercial Distribution

  • 04015630919680 ()
3507343190

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
3507246190
In Commercial Distribution

  • 04015630919666 ()
3507246190

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
Quantitative determination of IgA in human CSF and paired CSF/serum on BN Systems
Siemens Healthcare Diagnostics Products GmbH
10446036
In Commercial Distribution

  • 00842768007200 ()
OQAI11

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
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
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