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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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VITROS - 10758750001415

VITROS Immunodiagnostic Products Anti-HAV IgM Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801812
In Commercial Distribution

  • 10758750001415 ()
  • 20758750001412 ()
6801812

  • Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

VITROS - 10758750001286

VITROS Immunodiagnostic Products Anti-HAV Total Calibrator
ORTHO CLINICAL DIAGNOSTICS
6801462
In Commercial Distribution

  • 10758750001286 ()
  • 20758750001283 ()
6801462

  • Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassay

Light Diagnostics ™ Coxsackievirus B3 Monoclonal Antibody - 04053252404719

Coxsackievirus B3 Monoclonal Antibody
EMD Millipore Corporation
3306
Not in Commercial Distribution

  • 04053252404719 ()
3306

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics ™ Coxsackievirus A Control Slides - 04053252404290

Coxsackievirus A Control Slides
EMD Millipore Corporation
5076
Not in Commercial Distribution

  • 04053252404290 ()
5076

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics™ Coxsackievirus A24 Monoclonal Antibody - 04053252326011

Coxsackievirus A24 Monoclonal Antibody
EMD Millipore Corporation
3302
Not in Commercial Distribution

  • 04053252326011 ()
3302

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics ™ Influenza A FITC-Labeled Monoclonal Antibody - 04053252320439

Influenza A FITC-Labeled Monoclonal Antibody
EMD Millipore Corporation
5017
Not in Commercial Distribution

  • 04053252320439 ()
5017

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

Light Diagnostics ™ Coxsackie A9/A24 Control Slide - 04061841171737

Coxsackie A9/A24 Control Slide
EMD Millipore Corporation
50209
Not in Commercial Distribution

  • 04061841171737 ()
50209

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics ™ Coxsackie B Control Slide - 04061841171218

Coxsackie B Control Slide
EMD Millipore Corporation
50208
Not in Commercial Distribution

  • 04061841171218 ()
50208

  • Coxsackie A/B virus antigen IVD, reagent

SEEKER™ - 00819704020111

SEEKER™ GLA Reagent (alpha-D-galactosidase)
BAEBIES, INC.
1202
In Commercial Distribution

  • 00819704020111 ()
1202

  • Newborn metabolic screen/congenital disorder IVD, reagent

Influenza Virus A IgG ELISA - 00840239037930

The Influenza Virus A IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus A in human serum or plasma (citrate, heparin).
DRG International Inc
EIA-3793
In Commercial Distribution

  • 00840239037930 ()
EIA-3793

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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