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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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SPIFE Ultra ImmunoFix-9 Antisera Kit - M5255521640

No Description
HELENA LABORATORIES CORPORATION
552164
In Commercial Distribution

  • M5255521640 ()


  • Protein electrophoresis IVD, kit, electrophoresis

SPIFE Ultra ImmunoFix-6 Antisera Kit - M5255521630

No Description
HELENA LABORATORIES CORPORATION
552163
In Commercial Distribution

  • M5255521630 ()


  • Protein electrophoresis IVD, kit, electrophoresis

QuickGel IFE Blotter A and Templates - M5255521560

No Description
HELENA LABORATORIES CORPORATION
552156
In Commercial Distribution

  • M5255521560 ()


  • Protein electrophoresis IVD, kit, electrophoresis

SPIFE Ultra ImmunoFix-15 Antisera Kit - M5255521250

No Description
HELENA LABORATORIES CORPORATION
552125
In Commercial Distribution

  • M5255521250 ()


  • Protein electrophoresis IVD, kit, electrophoresis

SPIFE IFE Applicator Kit - M5255521240

No Description
HELENA LABORATORIES CORPORATION
552124
In Commercial Distribution

  • M5255521240 ()


  • Protein electrophoresis IVD, kit, electrophoresis

SPIFE ImmunoFix-15 Applicator Kit - M5255520920

No Description
HELENA LABORATORIES CORPORATION
552092
In Commercial Distribution

  • M5255520920 ()


  • Protein electrophoresis IVD, kit, electrophoresis

SPIFE IgG IEF Kit, Part 2 - M5255520890

No Description
HELENA LABORATORIES CORPORATION
552089
In Commercial Distribution

  • M5255520890 ()


  • Protein electrophoresis IVD, kit, electrophoresis

SPIFE ImmunoFix-9/15 Applicator Kit - M5255518500

No Description
HELENA LABORATORIES CORPORATION
551850
In Commercial Distribution

  • M5255518500 ()


  • Protein electrophoresis IVD, kit, electrophoresis

SPIFE ImmunoFix-9 Antisera Kit - M5255518410

No Description
HELENA LABORATORIES CORPORATION
551841
In Commercial Distribution

  • M5255518410 ()


  • Protein electrophoresis IVD, kit, electrophoresis

SPIFE ImmunoFix-3 Antisera Kit - M5255518320

No Description
HELENA LABORATORIES CORPORATION
551832
In Commercial Distribution

  • M5255518320 ()


  • Protein electrophoresis IVD, kit, electrophoresis

SPIFE ImmunoFix-6 Antisera Kit - M5255518220

No Description
HELENA LABORATORIES CORPORATION
551822
In Commercial Distribution

  • M5255518220 ()


  • Protein electrophoresis IVD, kit, electrophoresis

SPIFE ImmunoFix-3/6 Applicator Kit - M5255517160

No Description
HELENA LABORATORIES CORPORATION
551716
In Commercial Distribution

  • M5255517160 ()


  • Protein electrophoresis IVD, kit, electrophoresis

Citrate Buffer - M52551210

No Description
HELENA LABORATORIES CORPORATION
5121
In Commercial Distribution

  • M52551210 ()


  • Protein electrophoresis IVD, reagent

SPIFE IgG IEF-20 Kit - M52533850

No Description
HELENA LABORATORIES CORPORATION
3385
In Commercial Distribution

  • M52533850 ()


  • Protein electrophoresis IVD, kit, electrophoresis

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

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

Albumin Marker - M52590110

No Description
HELENA LABORATORIES CORPORATION
9011
In Commercial Distribution

  • M52590110 ()


  • Protein electrophoresis IVD, reagent

Normal Human Serum Control - M52590100

No Description
HELENA LABORATORIES CORPORATION
9010
In Commercial Distribution

  • M52590100 ()


  • Protein electrophoresis IVD, control

SPIFE Nexus IFE-9/15 Antisera Kit - M5255527440

No Description
HELENA LABORATORIES CORPORATION
552744
In Commercial Distribution

  • M5255527440 ()


  • Protein electrophoresis IVD, kit, electrophoresis

SPIFE Nexus Antisera 9/15 Kit - M5255526970

No Description
HELENA LABORATORIES CORPORATION
552697
In Commercial Distribution

  • M5255526970 ()


  • Protein electrophoresis IVD, kit, electrophoresis

SPIFE Nexus IFE-9 Gel Kit - M5255526950

No Description
HELENA LABORATORIES CORPORATION
552695
In Commercial Distribution

  • M5255526950 ()


  • Protein electrophoresis IVD, kit, electrophoresis
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