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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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ImmunoDOT Borrelia Positive Control - 00613745039053

This serum control contains IgG antibodies specific to Borrelia burgdorferi, the causative agent of Lyme Disease, and is to be used in conjunction with the appropriate ImmunoDOT Assay Test System.
Genbio
800-3905
In Commercial Distribution

  • 00613745039053 ()

  • 0.1 mL
3905

  • Borrelia burgdorferi immunoglobulin G (IgG) antibody IVD, control

West Nile Virus IgG Positive Control DxSelect™ - IgG Positive Control - 10816101022332

No Description
DIASORIN MOLECULAR LLC
EL0311
In Commercial Distribution

  • 10816101022332 ()
EL0311

  • West Nile virus immunoglobulin G (IgG) antibody IVD, control

Elecsys CMV IgG - 04015630940172

No Description
Roche Diagnostics GmbH
07027117190
In Commercial Distribution

  • 04015630940172 ()
07027117190

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Elecsys CMV IgG Assay - 04015630937172

No Description
Roche Diagnostics GmbH
7309325160
In Commercial Distribution

  • 04015630937172 ()
7309325160

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Adenovirus IgG ELISA - 00840239034465

The DRG Adenovirus IgG Enzyme Immunoassay Kit provides materials for the qualitative and semiquantitative determination of IgG-class antibodies to Adenovirus in serum
DRG International Inc
EIA-3446
In Commercial Distribution

  • 00840239034465 ()
EIA-3446

  • Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

CHORUS ADENOVIRUS IgG - 08033891327606

No Description
DIESSE DIAGNOSTICA SENESE SPA
81196
In Commercial Distribution

  • 08033891327606 ()
81196

  • Adenovirus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

VITROS - 10758750004997

VITROS Immunodiagnostic Products Rubella IgG Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
8536195
In Commercial Distribution

  • 10758750004997 ()
8536195

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay

Anti-Measles virus IFA (IgG) - 04049016079422

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2610-2010 G
Not in Commercial Distribution

  • 04049016079422 ()


  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Anti-Mumps virus IFA (IgG) - 04049016057475

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2630-1005 G
Not in Commercial Distribution

  • 04049016057475 ()


  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

Anti-Measles virus IFA (IgG) - 04049016057246

No Description
EUROIMMUN Medizinische Labordiagnostika AG
FI 2610-1010 G
Not in Commercial Distribution

  • 04049016057246 ()


  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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