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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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An enzyme linked immunosorbent assay for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum.
KRONUS, INC.
KR7730
In Commercial Distribution

  • B126KR77300 ()
KR7730

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)
An enzyme linked immunosorbent assay for the semi-quantitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.
KRONUS, INC.
KR7110
In Commercial Distribution

  • B126KR71100 ()
KR7110

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)
An enzyme linked immunosorbent assay for the qualitative determination of autoantibodies to steroid 21-hydroxylase (21-OH) in human serum.
KRONUS, INC.
KR7015
In Commercial Distribution

  • B126KR70150 ()
KR7015

  • Immunoglobulin G subclass (IgG subclass) 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
An enzyme linked immunosorbent assay for the semi-quantitative determination of autoantibodies to Aquaporin-4 in human serum.
KRONUS, INC.
KR8200
In Commercial Distribution

  • B126KR82000 ()
KR8200

  • Immunoglobulin G subclass (IgG subclass) IVD, kit, enzyme immunoassay (EIA)
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