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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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The ZEUS ELISA Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System provides a means for the qualitative detection of IgG antibodies to the nuclear antigen-1 of Epstein-Barr virus (EBNA-1) in human sera. When performed according to these instructions, the results of this test together with other testing, such as the heterophile test, and the EBV-VCA IgG and IgM tests, may aid in the diagnosis of, and provide information on infectious mononucleosis (IM), that may be of value in patient management and treatment. It is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
9Z9461G
In Commercial Distribution

  • 00845533000437 ()
9Z9461G

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
MONOFLUO Legionella pneumophila IFA Test Kit
Bio-RAD Laboratories, Inc.
32514
In Commercial Distribution

  • 00847865001496 ()

  • 24 Tests
32514

  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
The ZEUS IFA Epstein-Barr Virus Nuclear Antigen (EBV-NA) anti-complement immunofluorescence (ACIF) Test System is a relatively rapid and sensitive method for the qualitative and semi-quantitative detection of antibodies to the nuclear antigen of Epstein-Barr virus in human sera. When performed according to instructions, this assay can provide information on infectious mononucleosis (IM) that may be of value in patient management and treatment. This device is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
FA9153
In Commercial Distribution

  • 00845533001625 ()
FA9153

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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
Detection of Epstein Barr Nuclear Antigen
ARLINGTON SCIENTIFIC, INC.
NC-870096-AG
In Commercial Distribution

  • 00816057020638 ()

  • 96 Test
NC-870096-AG

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

  • 10634853000213 ()
200185

  • Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, control
MTS Anti-IgG,-C3d Card
MICRO TYPING SYSTEMS, INC
MTS084014
In Commercial Distribution

  • 10758750005987 ()
MTS084014

  • 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
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