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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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Light Diagnostics ™ Influenza B Monoclonal Antibody - 04053252473722

Influenza B Monoclonal Antibody
EMD Millipore Corporation
5018
Not in Commercial Distribution

  • 04053252473722 ()
5018

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

Light Diagnostics ™ Coxsackievirus B6 Monoclonal Antibody - 04053252472985

Coxsackievirus B6 Monoclonal Antibody
EMD Millipore Corporation
3309
Not in Commercial Distribution

  • 04053252472985 ()
3309

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics ™ Influenza A Monoclonal Antibody - 04053252470226

Influenza A Monoclonal Antibody
EMD Millipore Corporation
5001
Not in Commercial Distribution

  • 04053252470226 ()
5001

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

Light Diagnostics ™ Coxsackievirus B4 Monoclonal Antibody - 04053252408489

Coxsackievirus B4 Monoclonal Antibody
EMD Millipore Corporation
3307
Not in Commercial Distribution

  • 04053252408489 ()
3307

  • Coxsackie A/B virus antigen IVD, reagent

VITROS - 10758750008926

VITROS Immunodiagnostic Products Anti-HAV IgM Calibrator
ORTHO CLINICAL DIAGNOSTICS
1372101
In Commercial Distribution

  • 10758750008926 ()
  • 20758750008923 ()
1372101

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

VITROS - 10758750001477

VITROS Immunodiagnostic Products HAV Total Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6801823
In Commercial Distribution

  • 10758750001477 ()
  • 20758750001474 ()
6801823

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

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
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