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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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Positive Control for use with ImmunoFA Toxoplasma IgG kit.
Genbio
800-1204
In Commercial Distribution

  • 00613745012049 ()

  • 1.0 mL
1204

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
1. 1x H. pylori IgG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted H. pylori IgG ELISA Low Positive 4. 1x 1.2mL prediluted H. pylori IgG ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid
INOVA DIAGNOSTICS, INC.
708715
In Commercial Distribution

  • 08426950593256 ()


  • Helicobacter pylori 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
Not in Commercial Distribution

  • 08305900070040 ()


  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Diasorin Inc.
310831
In Commercial Distribution

  • 08056771600248 ()


  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, control
No Description
Diasorin Inc.
310621
In Commercial Distribution

  • 08056771600118 ()


  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control
No Description
DIASORIN S.P.A.
318240
In Commercial Distribution

  • 08056771500197 ()
  • 18056771500194 ()


  • Hepatitis C virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent 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)
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)
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