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ORTHO™ Sera Anti-D (ORTHO™ Sera Anti-D ) - India CDSCO Medical Device Registration

ORTHO™ Sera Anti-D (ORTHO™ Sera Anti-D ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000042_3a3a27aa65febc8fe9225cfcc37778c4_b63863cb43cd7be15c6b776cbe7b8fb9. This device is marketed under the brand name Ortho Confidence™ WB. The license holder is M/s. Ortho Clinical Diagnostics India 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
ORTHO™ Sera Anti-D (ORTHO™ Sera Anti-D )
UID: IMP/MD/2018/000042_3a3a27aa65febc8fe9225cfcc37778c4_b63863cb43cd7be15c6b776cbe7b8fb9

Brand Name

Ortho Confidence™ WB

Device Class

Class D

Approving Authority

CDSCO

Product Information

For in vitro diagnostic use only. For Direct Agglutination Test by Column Agglutination Technology. The Anti-D (Ortho Confidence™ WB) reagent is for the qualitative in vitro detection of human RhD positive red blood cells by the direct agglutination test. This Anti-D reagent will detect D category DVI cells

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