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MAGICL CYFRA21-1 - India CDSCO Medical Device Registration

MAGICL CYFRA21-1 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000403_b4d8b225108d4d198d73ad6b7c43c4e4_b4ee0ad1f5fbcbe1e2f56f9de1fd8fc2. This device is marketed under the brand name CLIA. The license holder is M/s. Reckon Diagnostics Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
MAGICL CYFRA21-1
UID: IMP/IVD/2019/000403_b4d8b225108d4d198d73ad6b7c43c4e4_b4ee0ad1f5fbcbe1e2f56f9de1fd8fc2

Brand Name

CLIA

Device Class

Class B

Approving Authority

CDSCO

Product Information

MAGICL CYFRA21-1 (CLIA) is intended for the in vitro quantitative determination of cytokeratin 19 fragment (CLIA) in human serum and plasma. Clinically, it is mainly used for curative effect observation and recurrence monitoring in patients with non-small cell lung cancer (CLIA)

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