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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 ZEUS ELISA Toxoplasma gondii IgG Test System is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
SM8Z8651G
In Commercial Distribution

  • 00845533001212 ()
SM8Z8651G

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Toxoplasma gondii IgG Test System is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
Q8Z8651GB
In Commercial Distribution

  • 00845533001205 ()
Q8Z8651GB

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Toxoplasma gondii IgG Test System is designed for the qualitative and/or quantitative determination of IgG antibodies to Toxoplasma gondii in human serum. The assay is intended to be used to evaluate serologic evidence of previous infection with T. gondii, and is for In Vitro diagnostic use. This product is not FDA cleared (approved) for use in screening blood or plasma donors.
ZEUS SCIENTIFIC, INC.
8Z8651G
In Commercial Distribution

  • 00845533001199 ()
8Z8651G

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
No Description
Bion Enterprises, Ltd.
CHG-4120
In Commercial Distribution

  • B110CHG41200 ()
CHG-4120

  • Multiple Chlamydia species immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
CBN-3310
Not in Commercial Distribution

  • B110CBN33100 ()
CBN-3310

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
CBG-3320
Not in Commercial Distribution

  • B110CBG33200 ()
CBG-3320

  • Coxsackie B virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
BBN-6110
In Commercial Distribution

  • B110BBN61100 ()
BBN-6110

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control
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)
No Description
Bion Enterprises, Ltd.
PN-8510
Not in Commercial Distribution

  • B110PN85100 ()
PN-8510

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, control
No Description
Bion Enterprises, Ltd.
PG-8520
Not in Commercial Distribution

  • B110PG85200 ()
PG-8520

  • Multiple human parainfluenza virus immunoglobulin G (IgG) antibody IVD, control
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