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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
Immunoglobulin A
Abbott GmbH
9D98-22
Not in Commercial Distribution

  • 00380740175177 ()
09D9822

  • 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
No Description
ALERE NORTH AMERICA, LLC
47050
In Commercial Distribution

  • 10859035006214 ()
  • 00859035006217 ()


  • Beta-haemolytic Group A Streptococcus total antibody IVD, kit, agglutination
1 QUANTA Flash HMGCR Reagent Cartridge. 1 Resuspension Buffer. 1 Transfer pipette.
INOVA DIAGNOSTICS, INC.
701333
In Commercial Distribution

  • 08426950793182 ()


  • 3-Hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibody IVD, kit, chemiluminescent immunoassay
No Description
HORIBA ABX SAS
1300023881
In Commercial Distribution

  • 03610230007334 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
2 x 2.5 ml REAGENT 1 x 1.5 ml CONTROL + 1 x 1.5 ml CONTROL – 2 x 9 SLIDES
BIOKIT, S.A.
3000-7010
In Commercial Distribution

  • 08426950457305 ()


  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, calibrator
No Description
Roche Diagnostics GmbH
3507343190
In Commercial Distribution

  • 04015630919680 ()
3507343190

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