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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_5735d332e5cd8b0f98d8797ec1dec96f. 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_5735d332e5cd8b0f98d8797ec1dec96f

Brand Name

Ortho Confidence™ WB

Device Class

Class D

Approving Authority

CDSCO

Product Information

For in vitro diagnostic use only. For Indirect Antiglobulin Test (Ortho Confidence™ WB) by Column Agglutination Technology. The Anti-D (Ortho Confidence™ WB) reagent is for the qualitative in vitro detection of human RhD blood group status by the indirect Antiglobulin test

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