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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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IgA/IgG FITC Conjugate w/EB
IMMCO DIAGNOSTICS, INC.
2113-15
In Commercial Distribution

  • 00845714003066 ()

  • 15 ml
2113-15

  • Human immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVD
IgA/IgG FITC Conjugate
IMMCO DIAGNOSTICS, INC.
2113X
In Commercial Distribution

  • 00845714003059 ()

  • 5 ml
2113X

  • Human immunoglobulin A (IgA)/IgG/IgM animal conjugate antibody reagent IVD
The DRG Epstein Barr Virus Early Antigen (EBV-EA) IgG ELISA test system provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2796
Not in Commercial Distribution

  • 04048474027969 ()
EIA-2796

  • Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
The DRG Epstein Barr Virus – Viral Capsid antigen (EBV-VCA) IgG test system is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG class antibodies to Epstein-Barr Virus Viral Capsid Antigen in human serum. The Test System is intended to be used to evaluate serologic evidence of previous infection with Epstein-Barr Virus,
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2793
Not in Commercial Distribution

  • 04048474027938 ()
EIA-2793

  • Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
Candida Antiserum, 2mL
MICROBIOLOGICS INC.
200185
Not in Commercial Distribution

  • 10634853000213 ()
200185

  • Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
An ELISA format for measuring IgG antibody against typhus group Rickettsia
FULLER LABORATORIES
N/A
In Commercial Distribution

  • B266RTG96K0 ()
RTG-96K

  • Multiple Rickettsia species (typhus group) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The DG Gel 8 Direct Coombs card is used for the evaluation of the Direct Antiglobulin Test of two different human blood samples. It allows to differentiate red blood cells sensitized in vivo by IgG type immunoglobulins or the complement C3d fractions. For use with the DG Gel System.
DIAGNOSTIC GRIFOLS SA
210129
In Commercial Distribution

  • 08437014205909 ()


  • Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination
Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 15X10ML Green
ORTHO-CLINICAL DIAGNOSTICS, INC.
716980
In Commercial Distribution

  • 10758750003624 ()
716980

  • Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination
Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 100X10ML Green
ORTHO-CLINICAL DIAGNOSTICS, INC.
716910
In Commercial Distribution

  • 10758750003600 ()
716910

  • Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination
Anti-IgG,-C3d; Polyspecific (Rabbit and Murine Monoclonal) BIOCLONE 15X10ML
ORTHO-CLINICAL DIAGNOSTICS, INC.
716080
In Commercial Distribution

  • 10758750003471 ()
716080

  • Multiple monospecific antihuman globulin/anti-complement cell coat typing IVD, kit, agglutination
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