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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 RIDASCREEN® Taenia solium IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Taenia solium and its cysticerci (bladder worms) in human serum. The test should be used for confirmation purposes when there is a suspected case of infection with Taenia solium.
R-Biopharm AG
K7721
Not in Commercial Distribution

  • 04049095110528 ()
K7721

  • Taenia solium immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The RIDASCREEN® Entamoeba histolytica IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Entamoeba histolytica in human serum. The test should be used for confirmation purposes when there is a suspected case of amoebiasis.
R-Biopharm AG
K1721
Not in Commercial Distribution

  • 04049095110023 ()
K1721

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Taenia solium IgG ELISA is intended for the qualitative determination of IgG class antibodies against Taenia solium in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
TAEG0420
In Commercial Distribution

  • ENTITAEG04200 ()
TAEG0420

  • Taenia solium immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Entamoeba histolytica IgG ELISA is intended for the qualitative determination of IgG class antibodies against Entamoeba histolytica in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
ENTG0140
In Commercial Distribution

  • ENTIENTG01400 ()
ENTG0140

  • Entamoeba histolytica immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
anti-IgG Rabbit Monoclonal Antibody [RM116], 10 RTU capsules
SAKURA FINETEK U.S.A., INC.
8383-C010
In Commercial Distribution

  • 00615233001979 ()
8383-C010

  • Human immunoglobulin G (IgG) rabbit conjugate antibody reagent IVD
anti-IgG Rabbit Monoclonal Antibody [RM116], 1 RTU cartridge
SAKURA FINETEK U.S.A., INC.
8383-M250
In Commercial Distribution

  • 00615233001962 ()
8383-M250

  • Human immunoglobulin G (IgG) rabbit conjugate antibody reagent IVD
No Description
IMMUNODIAGNOSTIC SYSTEMS LIMITED
IS-ID6502
In Commercial Distribution

  • 05060169695962 ()


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
SARS-CoV-2 IgG ELISA Kit
AGILENT TECHNOLOGIES, INC.
K1919
In Commercial Distribution

  • 05700571113011 ()

  • 180 tests


  • SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The HAMA IgG ELISA Test System is a direct enzyme-linked immunosorbent assay for the detection and semi-quantitation of human antibodies to mouse IgG (HAMA). The presence of human anti-mouse antibody (HAMA) has been associated with patients receiving injections of murine monoclonal antibody for diagnostic and/or therapeutic purposes.
ZEUS SCIENTIFIC, INC.
6401
In Commercial Distribution

  • 00845533001335 ()
6401

  • Human immunoglobulin G (IgG) murine conjugate antibody reagent IVD
PK7400 TP HA REAGENT is a hemagglutination assay intended for the qualitative screening of blood and plasma donors for the detection of Treponema pallidum IgG and IgM antibodies to syphilis in human serum, EDTA plasma or CPDA plasma using the Beckman Coulter PK7400 Automated Microplate System. This assay is not intended for diagnostic use.
NEWMARKET BIOMEDICAL LIMITED
B11186
In Commercial Distribution

  • 05060515140030 ()

  • 3600 tests


  • Treponema pallidum immunoglobulin G (IgG)/IgM antibody IVD, kit, agglutination
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