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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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FITC anti-IgG Goat Polyclonal Antibody, 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8535-M250
In Commercial Distribution

  • 00615233010575 ()
8535-M250

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
FITC anti-IgG Goat Polyclonal Antibody, 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8535-C010
In Commercial Distribution

  • 00615233002303 ()
8535-C010

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
The ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This assay is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
PF-SM3Z9661
In Commercial Distribution

  • 00845533001854 ()
PF-SM3Z9661

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS IFA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgG Test System is designed for the qualitative and semi-quantitative detection of EBV-VCA IgG antibodies in human serum and is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
FA9151G
In Commercial Distribution

  • 00845533001571 ()
FA9151G

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
IgG FITC Conjugate
IMMCO DIAGNOSTICS, INC.
2100X-8
In Commercial Distribution

  • 00845714003011 ()

  • 8 ml
2100X-8

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
IgG FITC Conjugate
IMMCO DIAGNOSTICS, INC.
2099X
In Commercial Distribution

  • 00845714002991 ()

  • 5 ml
2099X

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
IgG FITC Conjugate w/ Evans Blue
IMMCO DIAGNOSTICS, INC.
2100
In Commercial Distribution

  • 00845714002182 ()

  • 5 ml
2100

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
IgG FITC Conjugate w/ Evans Blue
IMMCO DIAGNOSTICS, INC.
2099
In Commercial Distribution

  • 00845714002175 ()

  • 5 ml
2099

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
IgG FITC Conjugate
IMMCO DIAGNOSTICS, INC.
2100X
In Commercial Distribution

  • 00845714003479 ()

  • 5 ml
2100X

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
No Description
SCIMEDX CORPORATION
I-EBV01X
In Commercial Distribution

  • 00813545025564 ()
I-EBV01X

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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