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
Bion Enterprises, Ltd.
HS1-3012
In Commercial Distribution

  • B110HS130120 ()
HS1-3012

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG)/IgM antibody IVD, reagent
For use with ImmunoFA Toxoplasma kits
Genbio
800-1207
Not in Commercial Distribution

  • 00613745012070 ()

  • 100 slides, 10 tests per slide
1207

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent
Negative control for use with ImmunoFA Toxoplasma kits.
Genbio
800-1203
Not in Commercial Distribution

  • 00613745012032 ()

  • 1.0 mL
1203

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent
Toxoplasma Slides for use with ImmunoFA Toxoplasma kits
Genbio
800-1201
Not in Commercial Distribution

  • 00613745012018 ()

  • 10 slides, 10 tests each slide
1201

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent
Mounting fluid for use with ImmunoFA kits.
Genbio
800-1025
Not in Commercial Distribution

  • 00613745010250 ()

  • 5 mL
1025

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent
10-fold concentrate of 0.01M PBS
Genbio
800-1006
Not in Commercial Distribution

  • 00613745010069 ()

  • 250 mL
1006

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent
10-fold concentrate of 0.01M PBS
Genbio
800-1005
Not in Commercial Distribution

  • 00613745010052 ()

  • 50 mL
1005

  • Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent
No Description
SEBIA
4642
In Commercial Distribution

  • 03607360046425 ()
4642

  • Multiple clinical chemistry protein IVD, reagent
No Description
SEBIA
4639
In Commercial Distribution

  • 03607360046395 ()
4639

  • Multiple clinical chemistry protein IVD, reagent
No Description
SEBIA
2602
In Commercial Distribution

  • 03607360026021 ()
2602

  • Multiple clinical chemistry protein IVD, reagent
No Description
SEBIA
2601
In Commercial Distribution

  • 03607360026014 ()
2601

  • Multiple clinical chemistry protein IVD, reagent
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
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
552392
In Commercial Distribution

  • M5255523920 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
552391
In Commercial Distribution

  • M5255523910 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
3385
In Commercial Distribution

  • M52533850 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
HELENA LABORATORIES CORPORATION
1825000
In Commercial Distribution

  • M52518250000 ()


  • Electrophoresis analyser IVD
No Description
HELENA LABORATORIES CORPORATION
1821
In Commercial Distribution

  • M52518210 ()


  • Protein electrophoresis IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
1820
In Commercial Distribution

  • M52518200 ()


  • Electrophoresis analyser IVD
No Description
HELENA LABORATORIES CORPORATION
1803
In Commercial Distribution

  • M52518030 ()


  • Protein electrophoresis IVD, reagent
No Description
HELENA LABORATORIES CORPORATION
1801000
In Commercial Distribution

  • M52518010000 ()


  • Electrophoresis analyser IVD
No Description
HELENA LABORATORIES CORPORATION
1800001
In Commercial Distribution

  • M52518000010 ()


  • Electrophoresis analyser IVD
No Description
HELENA LABORATORIES CORPORATION
1800000
In Commercial Distribution

  • M52518000000 ()


  • Electrophoresis analyser IVD
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
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
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