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CDSCO UID IMP/IVD/2019/000262_a0f5a0ebb96de845928e7265823952c1_df95d9a026d03b2b2aaa1a335d38e4ee

Determine™ HBsAg 2

Abbott Diagnostics Medical Private Limited·Device Class Class D·India CDSCO·Brand: Determine HIV Controls
Registration details
UID
IMP/IVD/2019/000262_a0f5a0ebb96de845928e7265823952c1_df95d9a026d03b2b2aaa1a335d38e4ee
Device class
Class D
Brand name
Determine HIV Controls
License holder
Abbott Diagnostics Medical Private Limited
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
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About this record

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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