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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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No Description
DIESSE DIAGNOSTICA SENESE SPA
81190
In Commercial Distribution

  • 08033891327514 ()
81190

  • Influenza A virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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
ACCURUN 135 Toxoplasma IgG 1 x 1.0 mL
Lgc Clinical Diagnostics, Inc.
2015-0082
In Commercial Distribution

  • 00816784020390 ()
2015-0082

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
"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
No Description
MONOBIND, INC.
1425-300
In Commercial Distribution

  • 00816870021102 ()

  • Width: 7.75 Inch
1425-300A

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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)
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)
VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on theVIDAS® instruments , for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA).
BIOMERIEUX SA
30192-01
In Commercial Distribution

  • 03573026509231 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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