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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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Immunofixation (IFE) Kit - 05051700011211

No Description
THE BINDING SITE GROUP LIMITED
XK001
Not in Commercial Distribution

  • 05051700011211 ()


  • Protein electrophoresis IVD, kit, electrophoresis

Human IgM - ‘NL’ BINDARID™ Radial Immunodiffusion Kit - 05051700010467

No Description
THE BINDING SITE GROUP LIMITED
RN012.3
Not in Commercial Distribution

  • 05051700010467 ()


  • Total immunoglobulin M (IgM total) IVD, kit, precipitation/immunodiffusion

Human IgA - ‘NL’ BINDARID™ Radial Immunodiffusion Kit - 05051700010450

No Description
THE BINDING SITE GROUP LIMITED
RN010.3
Not in Commercial Distribution

  • 05051700010450 ()


  • Total immunoglobulin A (IgA total) IVD, kit, precipitation/immunodiffusion

Hydrashift 2 4 isatuximab - 03607360046425

No Description
SEBIA
4642
In Commercial Distribution

  • 03607360046425 ()
4642

  • Multiple clinical chemistry protein IVD, reagent

HYDRASHIFT 2 4 daratumumab 20 tests - 03607360046395

No Description
SEBIA
4639
In Commercial Distribution

  • 03607360046395 ()
4639

  • Multiple clinical chemistry protein IVD, reagent

Sample Diluent CAPI 3 IT (10) - 03607360026021

No Description
SEBIA
2602
In Commercial Distribution

  • 03607360026021 ()
2602

  • Multiple clinical chemistry protein IVD, reagent

ANTISERA CAPI 3 IT (10) - 03607360026014

No Description
SEBIA
2601
In Commercial Distribution

  • 03607360026014 ()
2601

  • Multiple clinical chemistry protein IVD, reagent

V8 Nexus CE Analyzer (115V/230V) - M52518250000

No Description
HELENA LABORATORIES CORPORATION
1825000
In Commercial Distribution

  • M52518250000 ()


  • Electrophoresis analyser IVD

V8 Gel IFE Diluent Barcode Labels - M52518210

No Description
HELENA LABORATORIES CORPORATION
1821
In Commercial Distribution

  • M52518210 ()


  • Protein electrophoresis IVD, reagent

V8 WASTE DRAWER PACK - M52518200

No Description
HELENA LABORATORIES CORPORATION
1820
In Commercial Distribution

  • M52518200 ()


  • Electrophoresis analyser IVD

V8 Immunodisplacement Kit - M52518030

No Description
HELENA LABORATORIES CORPORATION
1803
In Commercial Distribution

  • M52518030 ()


  • Protein electrophoresis IVD, reagent

V8 E-Class Velocity CE Analyzer (220V) - M52518010000

No Description
HELENA LABORATORIES CORPORATION
1801000
In Commercial Distribution

  • M52518010000 ()


  • Electrophoresis analyser IVD

V8 Velocity CE Analyzer (110V) Inpeco Ready - M52518000010

No Description
HELENA LABORATORIES CORPORATION
1800001
In Commercial Distribution

  • M52518000010 ()


  • Electrophoresis analyser IVD

V8 Velocity CE Analyzer (110V) Not Inpeco Ready - M52518000000

No Description
HELENA LABORATORIES CORPORATION
1800000
In Commercial Distribution

  • M52518000000 ()


  • Electrophoresis analyser IVD

QuickGel Disposable IFE Sample Cup Strips - M52512580

No Description
HELENA LABORATORIES CORPORATION
1258
In Commercial Distribution

  • M52512580 ()


  • Protein electrophoresis IVD, kit, electrophoresis

SPIFE IgG IEF-20 Kit - M52533850

No Description
HELENA LABORATORIES CORPORATION
3385
In Commercial Distribution

  • M52533850 ()


  • Protein electrophoresis IVD, kit, electrophoresis

Citrate Buffer - M52551210

No Description
HELENA LABORATORIES CORPORATION
5121
In Commercial Distribution

  • M52551210 ()


  • Protein electrophoresis IVD, reagent

TITAN GEL IFE Antiserum Trivalent (G, A, M) - M52594110

No Description
HELENA LABORATORIES CORPORATION
9411
In Commercial Distribution

  • M52594110 ()


  • Polyvalent human immunoglobulin antibody IVD, reagent

Antiserum to Human Kappa Light Chain - M52592620

No Description
HELENA LABORATORIES CORPORATION
9262
In Commercial Distribution

  • M52592620 ()


  • Kappa/lambda light chain immunoglobulin IVD, antibody

Antiserum to Human Lambda Light Chain - M52592570

No Description
HELENA LABORATORIES CORPORATION
9257
In Commercial Distribution

  • M52592570 ()


  • Kappa/lambda light chain immunoglobulin IVD, antibody

Antisera to Human Immunoglobulins Pentavalent (G, A, M, D, E) - M52592510

No Description
HELENA LABORATORIES CORPORATION
9251
In Commercial Distribution

  • M52592510 ()


  • Polyvalent human immunoglobulin antibody IVD, reagent

Antiserum to Human IgE - M52592500

No Description
HELENA LABORATORIES CORPORATION
9250
In Commercial Distribution

  • M52592500 ()


  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

Antiserum to Human IgD - M52592490

No Description
HELENA LABORATORIES CORPORATION
9249
In Commercial Distribution

  • M52592490 ()


  • Immunoglobulin D subclass (IgD subclass) IVD, reagent

Antiserum to Human Immunoglobulins Trivalent (G, A, M) - M52592360

No Description
HELENA LABORATORIES CORPORATION
9236
In Commercial Distribution

  • M52592360 ()


  • Polyvalent human immunoglobulin antibody IVD, reagent

Antiserum to Human IgM - M52592340

No Description
HELENA LABORATORIES CORPORATION
9234
In Commercial Distribution

  • M52592340 ()


  • Immunoglobulin M subclass (IgM subclass) IVD, reagent

Antiserum to Human Serum - M52592330

No Description
HELENA LABORATORIES CORPORATION
9233
In Commercial Distribution

  • M52592330 ()


  • Polyvalent human immunoglobulin antibody IVD, reagent

Antiserum to Human IgG - M52592320

No Description
HELENA LABORATORIES CORPORATION
9232
In Commercial Distribution

  • M52592320 ()


  • Immunoglobulin G subclass (IgG subclass) IVD, reagent

Antiserum to Human IgA - M52592310

No Description
HELENA LABORATORIES CORPORATION
9231
In Commercial Distribution

  • M52592310 ()


  • Immunoglobulin A subclass (IgA subclass) IVD, reagent

Titan IV IEPlates - M52590610

No Description
HELENA LABORATORIES CORPORATION
9061
In Commercial Distribution

  • M52590610 ()


  • Protein electrophoresis IVD, kit, electrophoresis

Titan IV IEPlates - M52590500

No Description
HELENA LABORATORIES CORPORATION
9050
In Commercial Distribution

  • M52590500 ()


  • Protein electrophoresis IVD, kit, electrophoresis
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