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

ORTHO™ Sera Anti-Fyb is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000042_53a59091fce187adad08b53c7bc42b4c_374868a31920928b4944207c623b8cb2. 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-Fyb
UID: IMP/MD/2018/000042_53a59091fce187adad08b53c7bc42b4c_374868a31920928b4944207c623b8cb2

Brand Name

ORTHO™ Sera Anti-P1

Device Class

Class D

Approving Authority

CDSCO

Product Information

For in vitro diagnostic use only. For Indirect Antiglobulin Test by Column Agglutination Technology. The Anti-Fyb reagent is for the qualitative in vitro detection of human Fyb positive red blood cells by the indirect antiglobulin test

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