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

ORTHO™ Sera Anti-Jka is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000042_b6ea83b4eb059ca854e51e7e8bee2771_eb74c50c3005b3b19039f440796d0dcf. 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-Jka
UID: IMP/MD/2018/000042_b6ea83b4eb059ca854e51e7e8bee2771_eb74c50c3005b3b19039f440796d0dcf

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

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