Clarus AGM EIA - India CDSCO Medical Device Registration

Clarus AGM EIA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000296_7d8e48b2bbf49676c56431147d31862e_d3fd46d1aec0678ebe362b76bb731200. This device is marketed under the brand name sona Aspergillus GM LFA. The license holder is Taevas Life Sciences 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

Clarus AGM EIA

UID: IMP/IVD/2019/000296_7d8e48b2bbf49676c56431147d31862e_d3fd46d1aec0678ebe362b76bb731200

Brand Name

sona Aspergillus GM LFA

License Holder

Taevas Life Sciences Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The clarus Aspergillus Galactomannan EIA (sona Aspergillus GM LFA) is an immunoenzymatic, sandwich microplate assay used for the qualitative detection of Aspergillus galactomannan in serum and bronchoalveolar lavage (sona Aspergillus GM LFA) samples from patients at-risk for invasive aspergillosis. The clarus AGM EIA is a test which can be used as an aid in the diagnosis of aspergillosis when tested in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples, and radiographic evidence. It is intended for laboratory professional use.

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