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CDSCO UID IMP/MD/2018/000042_34b68758edc2ef89c88e57dd46ba6642_fcc159f79a09636ee6777a546370e4b2

ORTHO™ Sera Anti-Lea

M/s. Ortho Clinical Diagnostics India Private Limited·Device Class Class D·India CDSCO·Brand: Ortho Confidence™ WB
Registration details
UID
IMP/MD/2018/000042_34b68758edc2ef89c88e57dd46ba6642_fcc159f79a09636ee6777a546370e4b2
Device class
Class D
Brand name
Ortho Confidence™ WB
License holder
M/s. Ortho Clinical Diagnostics India Private Limited
Approving authority
CDSCO
Product information
For in vitro diagnostic use only. For Direct Agglutination Test by Column Agglutination Technology. The Anti-Lea reagent is for the qualitative in vitro detection of human Lea positive red blood cells by the direct agglutination test.
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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
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About this record

ORTHO™ Sera Anti-Lea is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000042_34b68758edc2ef89c88e57dd46ba6642_fcc159f79a09636ee6777a546370e4b2. 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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