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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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SEEKER™ - 00819704020111

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

  • 00819704020111 ()
1202

  • Newborn metabolic screen/congenital disorder IVD, reagent

Optilite Hevylite® IgA Kappa Kit - 05051700018487

No Description
THE BINDING SITE GROUP LIMITED
NK623.OPT.A
In Commercial Distribution

  • 05051700018487 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Hevylite® Human IgA Kappa Kit for use on the SPAPLUS - 05051700017985

No Description
THE BINDING SITE GROUP LIMITED
NK623.S.A
In Commercial Distribution

  • 05051700017985 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry

Influenza Virus B IgG ELISA - 04048474037968

The Influenza Virus B IgG ELISA is intended for the qualitative determination of IgG class antibodies against Influenza Virus B in human serum or plasma (citrate, heparin).
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-3796
In Commercial Distribution

  • 04048474037968 ()
EIA-3796

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

Influenza Virus A IgG ELISA - 04048474037937

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 Instruments Gesellschaft mit beschränkter Haftung
EIA-3793
In Commercial Distribution

  • 04048474037937 ()
EIA-3793

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

Light Diagnostics ™ Influenza A & B Control Slide - 04053252789229

Influenza A & B Control Slide
EMD Millipore Corporation
5010
Not in Commercial Distribution

  • 04053252789229 ()
5010

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

Light Diagnostics ™ Coxsackievirus B Blend Monoclonal Antibodies - 04053252734557

Coxsackievirus B Blend Monoclonal Antibodies
EMD Millipore Corporation
3303
Not in Commercial Distribution

  • 04053252734557 ()
3303

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics ™ Coxsackievirus B Control Slides - 04053252729225

Coxsackievirus B Control Slides
EMD Millipore Corporation
5075
Not in Commercial Distribution

  • 04053252729225 ()
5075

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics™ Coxsackievirus A9 Monoclonal Antibody - 04053252672989

Coxsackievirus A9 Monoclonal Antibody
EMD Millipore Corporation
3301
Not in Commercial Distribution

  • 04053252672989 ()
3301

  • Coxsackie A/B virus antigen IVD, reagent

Light Diagnostics ™ Coxsackie Antibody Set - 04053252585258

Coxsackie Antibody Set
EMD Millipore Corporation
3350
Not in Commercial Distribution

  • 04053252585258 ()
3350

  • Coxsackie A/B virus antigen IVD, reagent
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