SD BIOLINE Leptospira - India CDSCO Medical Device Registration

SD BIOLINE Leptospira is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000156_83b347429352063f21f0e969eb9efb3b_2b019bfb8322024e4eeb758d45cea7cf. 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 Leptospira

UID: IMP/MD/2018/000156_83b347429352063f21f0e969eb9efb3b_2b019bfb8322024e4eeb758d45cea7cf

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