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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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Pointe Scientific, Inc. Toxoplasma IgG Reagent is for the qualitative, semi-quantitative or quantitative detection of human IgG antibodies to Toxoplasma gondii in human serum by enzyme immunoassay, as an aid in the determination of infection with Toxoplasma. When used as a qualitative test, Toxoplasma IgG EIA aids in the assessment of the patient's immunological response to toxoplasma. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests
POINTE SCIENTIFIC, INC.
T8001-96
In Commercial Distribution

  • 00811727015150 ()
T81001-96

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Simpli 8mm Pen Needle UltiGuard
ULTIMED, INC.
74505
In Commercial Distribution

  • 30357515745058 ()
  • 20357515745051 ()
  • 00357515710055 ()


  • Cryptosporidium species immunoglobulin G (IgG) antibody IVD, calibrator
Simpli 6mm Pen Needle UltiGuard
ULTIMED, INC.
74503
In Commercial Distribution

  • 30357515745034 ()
  • 20357515745037 ()
  • 00357515710147 ()


  • Cryptosporidium species immunoglobulin G (IgG) antibody IVD, calibrator
No Description
DIASORIN MOLECULAR LLC
EL0920G-5
In Commercial Distribution

  • 20816101022193 ()
EL0920G-5

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
EL0920G
In Commercial Distribution

  • 20816101022186 ()
EL0920G

  • Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
EL0910G-5
In Commercial Distribution

  • 20816101022155 ()
EL0910G-5

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
DIASORIN MOLECULAR LLC
EL0910G
In Commercial Distribution

  • 20816101022148 ()
EL0910G

  • Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Trichinella spiralis IgG ELISA is intended for the qualitative determination of IgG class antibodies against Trichinella spiralis in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
TRIG0480
In Commercial Distribution

  • ENTITRIG04800 ()
TRIG0480

  • Trichinella spiralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Toxocara canis IgG ELISA is intended for the qualitative determination of IgG class antibodies against Toxocara canis in human serum or plasma (citrate, heparin).
Gold Standard Diagnostics Frankfurt GmbH
TOCG0450
In Commercial Distribution

  • ENTITOCG04500 ()
TOCG0450

  • Toxocara canis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The Strongyloides ELISA is intended for the qualitative determination of antibodies against Strongyloides in human serum or plasma (citrate or heparin).
Gold Standard Diagnostics Frankfurt GmbH
STRO0690
In Commercial Distribution

  • ENTISTRO06900 ()
STRO0690

  • Strongyloides stercoralis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
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