SD BIOLINE Troponin I - India CDSCO Medical Device Registration

SD BIOLINE Troponin I is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000156_3ae63d40ee3ec39b926d78e6f34403b5_f45ff8aa86a8592e90879a4caa098006. This device is marketed under the brand name SD BIOLINE Influenza Antigen. The license holder is Abbott Diagnostics Medical Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

SD BIOLINE Troponin I

UID: IMP/MD/2018/000156_3ae63d40ee3ec39b926d78e6f34403b5_f45ff8aa86a8592e90879a4caa098006

Brand Name

SD BIOLINE Influenza Antigen

License Holder

Abbott Diagnostics Medical Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The SD BIOLINE Troponin I is an in-vitro immunochromatographic, one step assay designed for qualitative determination of cardiac Troponin I (SD BIOLINE Influenza Antigen) in human serum, plasma or whole blood. SD BIOLINE Troponin I is intended for professional use, only for L and positive samples should be confirmed by a supplemental assay such as Electrocardiogram or Coronary angiogram. This kit is for in vitro diagnostic use only