Genbio

Address:15222 AVE. OF SCIENCE,Rancho Bernardo,CA,92128,US

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- Catalog Number : 1203

Device Description : Negative control for use with ImmunoFA Toxoplasma kits.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : GLZ

Prescription Use : No

Device Count : 1

- Catalog Number : 1204

Device Description : Positive Control for use with ImmunoFA Toxoplasma IgG kit.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : GLZ

Prescription Use : No

Device Count : 1

- Catalog Number : 1205

Device Description : Positive control for use with ImmunoFA Toxoplasma IgG kit.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : GLZ

Prescription Use : No

Device Count : 1

- Catalog Number : 1207

Device Description : For use with ImmunoFA Toxoplasma kits

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : GLZ

Prescription Use : No

Device Count : 1

- Catalog Number : 1300

Device Description : The ImmunoFA Toxo IgM Test is an immunofluorescence test for the presumptive det The ImmunoFA Toxo IgM Test is an immunofluorescence test for the presumptive detection and titration of IgM antibodies to Toxoplasma gondii in human serum and is presumptive for the diagnosis of acute, recent, or reactivated T. gondii infection. It is intended that the ImmunoFA Toxo IgG Test be performed in conjunction with this assay. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : GLZ

Prescription Use : No

Device Count : 1

- Catalog Number : 1309

Device Description : Conjugate for use with ImmunoFA Toxoplasma IgM kit.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : GLZ

Prescription Use : No

Device Count : 1

- Catalog Number : 1341

Device Description : Positive control for use with ImmunoFA Toxoplasma IgM kit.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : GLZ

Prescription Use : No

Device Count : 1

- Catalog Number : 3020

Device Description : The ImmunoWELL TPO IgG Quantitative Test is a quantitative enzyme immunoassay (E The ImmunoWELL TPO IgG Quantitative Test is a quantitative enzyme immunoassay (EIA) for screening and detection of autoantibodies against human thyroid peroxidase (microsome) in serum and is used as an aid in the diagnosis of thyroid disorders.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : JNL

Prescription Use : No

Device Count : 1

- Catalog Number : 3030

Device Description : The ImmunoWELL Thyroglobulin IgG Quantitative Test is a quantitative enzyme immu The ImmunoWELL Thyroglobulin IgG Quantitative Test is a quantitative enzyme immunoassay (EIA) for screening and detection of autoantibodies against human thyroglobulin in serum and is used as an aid in the diagnosis of thyroid disorders.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : JNL

Prescription Use : No

Device Count : 1

- Catalog Number : 3090

Device Description : The ImmunoWELL Cardiolipin Antibody (IgG) Test is an enzyme immunoassay (EIA) fo The ImmunoWELL Cardiolipin Antibody (IgG) Test is an enzyme immunoassay (EIA) for the quantitative detection of antibodies to cardiolipin antigen in serum and is used as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders.

Device Class : 2

Duns Number: 940425333

Premarket Exempt : No

Product Code : MID

Prescription Use : No

Device Count : 1