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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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No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2691-9601-1 G
Not in Commercial Distribution

  • 04049016028321 ()


  • Influenza A/B virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
EI 2189-9601 G
In Commercial Distribution

  • 04049016027560 ()


  • Multiple Brucella species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Mumps Control Slide
EMD Millipore Corporation
5029
Not in Commercial Distribution

  • 04061839704138 ()
5029

  • Mumps virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
No Description
BIOCARE MEDICAL LLC
API3115AA
In Commercial Distribution

  • 00847627004208 ()


  • Adenovirus immunoglobulin G (IgG) antibody IVD, reagent
No Description
BIOCARE MEDICAL LLC
ACI3115B
In Commercial Distribution

  • 00847627003010 ()


  • Adenovirus immunoglobulin G (IgG) antibody IVD, reagent
No Description
BIOCARE MEDICAL LLC
ACI3115A
In Commercial Distribution

  • 00847627003003 ()


  • Adenovirus immunoglobulin G (IgG) antibody IVD, reagent
The ZEUS IFA Herpes Simplex Virus-2 (HSV-2) IgG Test System is designed for the qualitative and semi-quantitative detection of Herpes Virus Hominis Antibody in human serum by the indirect fluorescent (IFA) technique and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
FA9052G
In Commercial Distribution

  • 00845533001564 ()
FA9052G

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay
VIROTROL Chagas (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00125X
In Commercial Distribution

  • 00847661002932 ()
00125X

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, control
VIROTROL Chagas (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00125
In Commercial Distribution

  • 00847661002925 ()
00125

  • Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, control
VIROTROL WNV (An unassayed (human) serology control.)
BIO-RAD LABORATORIES, INC.
00116
In Commercial Distribution

  • 00847661002628 ()
00116

  • West Nile virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
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