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ORTHO™ Sera Anti-M - India CDSCO Medical Device Registration

ORTHO™ Sera Anti-M is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000042_ee7c22ddb4a98a4a8f291ce98ce8c009_474e4a746d727e5be07e3937c90f7f00. This device is marketed under the brand name ORTHO™ Sera Anti-P1. The license holder is M/s. Ortho Clinical Diagnostics India Private Limited ,Gala No. 20, Gr. Fl., Warehouse No.7B, BGR Logistics Park , NH-3 , Village Vahuli, Post.Padgha, Tal.-Bhiwandi, Dist -Thane ,Thane Maharashtra ,421302 ,India, 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-M
UID: IMP/MD/2018/000042_ee7c22ddb4a98a4a8f291ce98ce8c009_474e4a746d727e5be07e3937c90f7f00

Brand Name

ORTHO™ Sera Anti-P1

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-M reagent is for the qualitative in vitro detection of human M positive red blood cells by the direct agglutination test

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