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

ORTHO™ Sera Anti-N is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000042_8503bc1a235a8249b0801a4c4dceef19_dc4ea559a4ac47041689248c072179c0. 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-N

UID: IMP/MD/2018/000042_8503bc1a235a8249b0801a4c4dceef19_dc4ea559a4ac47041689248c072179c0

Brand Name

Ortho Confidence™ WB

License Holder

M/s. Ortho Clinical Diagnostics India Private Limited

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

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Ortho Confidence WB

Brand: Ortho Confidence™ WB

M/s. Ortho Clinical Diagnostics India Private Limited

Class D

ORTHO™ Sera Anti-N

Brand: ORTHO™ Sera Anti-P1

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

Class D