SD BIOLINE Tsutsugamushi - India CDSCO Medical Device Registration

SD BIOLINE Tsutsugamushi is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000156_a49491e6a7613c1d24f7f852f85cae84_96c5dceb440c749f100a36422e758e3e. This device is marketed under the brand name SD BIOLINE Dengue IgG/IgM WB. The license holder is Abbott Diagnostics Medical Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

SD BIOLINE Tsutsugamushi

UID: IMP/MD/2018/000156_a49491e6a7613c1d24f7f852f85cae84_96c5dceb440c749f100a36422e758e3e

Brand Name

SD BIOLINE Dengue IgG/IgM WB

License Holder

Abbott Diagnostics Medical Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The SD BIOLINE Tsutsugamushi is a rapid, qualitative test for the detection of antibodies of IgG, IgM and IgA specific to Orientia tsutsugamushi in human serum, plasma or whole blood. The SD BIOLINE Tsutsugamushi is intended only for an initial screening test and reactive samples should be confirmed by a supplemental assay such as ELISA, PHA or IFA (SD BIOLINE Dengue IgG/IgM WB) reference test