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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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Alinity c Immunoglobulin A Reagent Kit 360 Tests
Abbott GmbH
09P6120
In Commercial Distribution

  • 00380740153915 ()
09P6120

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
Alinity c ASO Calibrator
ABBOTT LABORATORIES
01R0602
In Commercial Distribution

  • 00380740153540 ()
01R0602

  • Beta-haemolytic Group A Streptococcus streptolysin O 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
RANDOX LABORATORIES LIMITED
LO2306
In Commercial Distribution

  • 05055273204285 ()


  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator
Time resolved fluorescence immunoassay for the qualitative detection of Strep A specific carbohydrate antigen from throat swabs specimen to aid in the diagnosis of Group A Streptococcal infection.
NANO-DITECH CORPORATION
TF8149
In Commercial Distribution

  • 10895160002707 ()
  • 00895160002700 ()


  • Beta-haemolytic Group A Streptococcus antigen IVD, kit, fluorescent immunoassay
No Description
Roche Diagnostics GmbH
20737755322
In Commercial Distribution

  • 04015630913411 ()
20737755322

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
No Description
Roche Diagnostics GmbH
5219205190
In Commercial Distribution

  • 04015630925728 ()
5219205190

  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
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
No Description
ALERE NORTH AMERICA, LLC
46050
In Commercial Distribution

  • 10859035006221 ()
  • 00859035006224 ()


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