SD BIOLINE Tsutsugamushi
- UID
- IMP/MD/2018/000156_a49491e6a7613c1d24f7f852f85cae84_96c5dceb440c749f100a36422e758e3e
- Device class
- Class B
- Brand name
- SD BIOLINE Dengue IgG/IgM WB
- License holder
- Abbott Diagnostics Medical Private Limited
- 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
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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