Toxoplasma IgG/IgM Rapid Test Cassette - India CDSCO Medical Device Registration
Toxoplasma IgG/IgM Rapid Test Cassette is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000111_e75c01368bc49ca1591659fe7fa0e0cc_41dee4cbea7b00042c7c5b3fa877ad4d. This device is marketed under the brand name Mediline-SA. The license holder is S.A-MEDLINE PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.
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Brand Name
Mediline-SA
License Holder
S.A-MEDLINE PRIVATE LIMITEDDevice Class
Approving Authority
CDSCO -North Zone, Ghaziabad
Product Information
The Toxo IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM anti-Toxoplasma Gondii (Mediline-SA) and IgG anti-T. gondii in human whole blood, serum or plasma. This kit is intended to be used as a screening test and as an aid in the diagnosis of infection with T. gondii. Any reactive specimen with the Toxo IgG/IgM Rapid Test Cassette must be confirmed with alternative testing method(Mediline-SA) and clinical findings
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