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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 DRG Helicobacter pylori IgG ELISA is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. pylori in sera from symptomatic adults.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2815
Not in Commercial Distribution

  • 04048474028157 ()
EIA-2815

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Varicella-Zoster Virus (VZV) IgG ELISA test system is intended for the qualitative detection of VZV IgG antibody in human serum. When performed according to these instructions, the results of this test, together with other clinical information, may aid in the determination of immune status, and/or aid in the diagnosis of VZV infections.
DRG Instruments Gesellschaft mit beschränkter Haftung
EIA-2808
In Commercial Distribution

  • 04048474028089 ()
EIA-2808

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
The GAP-IgG is an ELISA test for the qualitative detection of IgG specific antibodies to Helicobacter pylori (H. pylori) in human serum. It is a serum test which, when used with other clinical information, can be used as an aid in the diagnosis of infection caused by H. pylori.
BIOMERICA, INC.
7004
In Commercial Distribution

  • 00083059070040 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
"720-650 EBV-EA-D IgM Test Kit"
DIAMEDIX CORPORATION
720-650
In Commercial Distribution

  • 00817273020365 ()


  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot
"720-620 EBNA-1 IgG Test Kit"
DIAMEDIX CORPORATION
720-620
In Commercial Distribution

  • 00817273020334 ()


  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot
"720-600 EBV-VCA IgG Test Kit"
DIAMEDIX CORPORATION
720-600
In Commercial Distribution

  • 00817273020310 ()


  • Cryptosporidium parvum immunoglobulin G (IgG) antibody IVD, kit, immunoblot
Detection of Varicella Zoster Antibody
ARLINGTON SCIENTIFIC, INC.
NC-840096-AG
In Commercial Distribution

  • 00816057020584 ()

  • 96 Test
NC-840096-AG

  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
SCIMEDX CORPORATION
I-RSV01X
In Commercial Distribution

  • 00813545026134 ()
I-RSV01X

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
No Description
SCIMEDX CORPORATION
I-RSV01G
In Commercial Distribution

  • 00813545026127 ()
I-RSV01G

  • Respiratory syncytial virus (RSV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
ACCURUN 190 Anti - Trypanosoma cruzi 6 x 3.5 mL
Lgc Clinical Diagnostics, Inc.
2015-0097
In Commercial Distribution

  • 00816784020499 ()
2015-0097

  • Trypanosoma cruzi immunoglobulin G (IgG) antibody IVD, control
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