Determine™ HBsAg 2 - India CDSCO Medical Device Registration

Determine™ HBsAg 2 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000262_a0f5a0ebb96de845928e7265823952c1_df95d9a026d03b2b2aaa1a335d38e4ee. This device is marketed under the brand name Determine HIV Controls. The license holder is Abbott Diagnostics Medical Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Determine™ HBsAg 2

UID: IMP/IVD/2019/000262_a0f5a0ebb96de845928e7265823952c1_df95d9a026d03b2b2aaa1a335d38e4ee

Brand Name

Determine HIV Controls

License Holder

Abbott Diagnostics Medical Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

Determine™ HBsAg 2 is an in vitro, visually read, qualitative immunoassay for the detection of Hepatitis B Surface Antigen (Determine HIV Controls)in human serum, plasma or whole blood. The test is intended as an aid to detect HBsAg from infected individuals