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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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Custom - EBNA FA BP - 3900 wells
IMMUNO CONCEPTS INC
8131
In Commercial Distribution

  • M7490081311 ()
8131

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
EB NA G
In Commercial Distribution

  • 00850487007364 ()
Q01-460

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

  • 00850487007166 ()
Q01-460

  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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. The performance characteristics have not been established to aid in the diagnosis of acute IM.
DRG International Inc
EIA-2796
Not in Commercial Distribution

  • 00840239027962 ()
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 International Inc
EIA-2793
Not in Commercial Distribution

  • 00840239027931 ()
EIA-2793

  • Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN SPA
310520
In Commercial Distribution

  • 08056771101752 ()


  • Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
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)
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)
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)
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
Mallet, , dia. , stainless steel, g, g
Avalign Technologies, Inc.
1-FL036R
In Commercial Distribution

  • 00190776183882 ()


  • Surgical mallet
G&G ANGLED WEDGE BUNDLE BARIATRIC
Asp Global, LLC
GGTS08B
In Commercial Distribution

  • 00840216117655 ()


  • Freestanding patient positioner, reusable
G&G ANGLED WEDGE BUNDLE STANDARD
Asp Global, LLC
GGTS08
In Commercial Distribution

  • 00840216117648 ()


  • Freestanding patient positioner, reusable
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
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
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
"720-350 HSV 1&2 IgM Test Kit"
DIAMEDIX CORPORATION
720-350
In Commercial Distribution

  • 00817273020181 ()


  • Multiple Candida species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, enzyme immunoassay (EIA)
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