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
SURGISTAR, INC.
8119
In Commercial Distribution

  • 10878799002706 ()
  • 00878799002709 ()


  • Manual scalpel blade, single-use
Pastorex Staph-Plus
BIO-RAD
56356
In Commercial Distribution

  • 03610520000960 ()

  • 1 x 50 tests
56356

  • Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Pastorex Staph-Plus
BIO-RAD
56353
In Commercial Distribution

  • 03610520000953 ()

  • 5 x 50 tests
56353

  • Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
No Description
HELENA LABORATORIES CORPORATION
9411
In Commercial Distribution

  • M52594110 ()


  • Polyvalent human immunoglobulin antibody IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
9262
In Commercial Distribution

  • M52592620 ()


  • Kappa/lambda light chain immunoglobulin IVD, antibody
No Description
HELENA LABORATORIES CORPORATION
9257
In Commercial Distribution

  • M52592570 ()


  • Kappa/lambda light chain immunoglobulin IVD, antibody
No Description
HELENA LABORATORIES CORPORATION
9251
In Commercial Distribution

  • M52592510 ()


  • Polyvalent human immunoglobulin antibody IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
9250
In Commercial Distribution

  • M52592500 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
9249
In Commercial Distribution

  • M52592490 ()


  • Immunoglobulin D subclass (IgD subclass) IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
9236
In Commercial Distribution

  • M52592360 ()


  • Polyvalent human immunoglobulin antibody IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
9234
In Commercial Distribution

  • M52592340 ()


  • Immunoglobulin M subclass (IgM subclass) IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
9233
In Commercial Distribution

  • M52592330 ()


  • Polyvalent human immunoglobulin antibody IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
9232
In Commercial Distribution

  • M52592320 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
9231
In Commercial Distribution

  • M52592310 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
9061
In Commercial Distribution

  • M52590610 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
9050
In Commercial Distribution

  • M52590500 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
9011
In Commercial Distribution

  • M52590110 ()


  • Protein electrophoresis IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
9010
In Commercial Distribution

  • M52590100 ()


  • Protein electrophoresis IVD, control
No Description
HELENA LABORATORIES CORPORATION
552744
In Commercial Distribution

  • M5255527440 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552737
In Commercial Distribution

  • M5255527370 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552703
In Commercial Distribution

  • M5255527030 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552697
In Commercial Distribution

  • M5255526970 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552695
In Commercial Distribution

  • M5255526950 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552694
In Commercial Distribution

  • M5255526940 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552597
In Commercial Distribution

  • M5255525970 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552596
In Commercial Distribution

  • M5255525960 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552595
In Commercial Distribution

  • M5255525950 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552594
In Commercial Distribution

  • M5255525940 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552583
In Commercial Distribution

  • M5255525830 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552580
In Commercial Distribution

  • M5255525800 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552579
In Commercial Distribution

  • M5255525790 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552578
In Commercial Distribution

  • M5255525780 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552563
In Commercial Distribution

  • M5255525630 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552560
In Commercial Distribution

  • M5255525600 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552559
In Commercial Distribution

  • M5255525590 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552472
In Commercial Distribution

  • M5255524720 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552457
In Commercial Distribution

  • M5255524570 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552454
In Commercial Distribution

  • M5255524540 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552440
In Commercial Distribution

  • M5255524400 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552398
In Commercial Distribution

  • M5255523980 ()


  • Protein electrophoresis IVD, kit, electrophoresis
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