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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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Rodent Tissue IgG Fluorescent Antibody Reagent 1 x 9ml.
IMMUNO CONCEPTS INC
12009-02 (1)
In Commercial Distribution

  • M749120090211 ()
12009-02 (1)

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
ANCA IgG Fluorescent Antibody Reagent - 1 x 9 mls.
IMMUNO CONCEPTS INC
10009-11 (1)
In Commercial Distribution

  • M749100091111 ()
10009-11 (1)

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB VCA G
In Commercial Distribution

  • 00850487007180 ()
Q01-470

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB VCA G
In Commercial Distribution

  • 00850487007371 ()
Q01-470

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The MERIFLUOR EBV-EA IgG IFA Test is a sensitive and rapid immunofluorescence method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human serum. When performed according to instructions, the MERIFLUOR EBV-EA IgG IFA Test detects IgG antibodies to the diffuse (D) and restricted (R) components of the EBV-EA complex. It is of value in providing supportive information for the diagnosis of EBV associated disease.
MERIDIAN BIOSCIENCE, INC.
EA101
Not in Commercial Distribution

  • 00840733103247 ()
EA101

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
An immunofluorescence test for the detection of EBV VCA IgG Antibodies to Epstein-Barr Virus.
MERIDIAN BIOSCIENCE, INC.
EB100
Not in Commercial Distribution

  • 00840733101939 ()
EB100

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
GullSORB is an antihuman IgG reagent used to eliminate IgG interference in human serum containing both IgM and IgG. This reagent has been standardized for use with IgM IFA assays manufactured by Meridian Bioscience, Inc.
MERIDIAN BIOSCIENCE, INC.
XX715
Not in Commercial Distribution

  • 00840733101304 ()
XX715

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
No Description
DIASORIN MOLECULAR LLC
IF0010
Not in Commercial Distribution

  • 10816101020017 ()


  • Legionella pneumophila immunoglobulin A (IgA)/IgG/IgM antibody IVD, reagent
No Description
Ventana Medical Systems, Inc.
05267919001
In Commercial Distribution

  • 04015630971497 ()
05267919001

  • Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
The Borrelia burgdorferi IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgM class antibody to Borrelia burgdorferi in human serum. This assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme disease.
DRG International Inc
EIA-2811
In Commercial Distribution

  • 00840239028112 ()
EIA-2811

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
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