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CDSCO UID IMP/MD/2018/000042_53a59091fce187adad08b53c7bc42b4c_374868a31920928b4944207c623b8cb2

ORTHO™ Sera Anti-Fyb

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·Device Class Class D·India CDSCO·Brand: ORTHO™ Sera Anti-P1
Registration details
UID
IMP/MD/2018/000042_53a59091fce187adad08b53c7bc42b4c_374868a31920928b4944207c623b8cb2
Device class
Class D
Brand name
ORTHO™ Sera Anti-P1
License holder
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
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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ORTHO™ Sera Anti-M
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
ORTHO™ Sera Anti-Fya
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
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ORTHO™ Sera Anti-Jka
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
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ORTHO™ Sera Anti-S
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
ORTHO™ Sera Anti-P1
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
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
ORTHO™ Sera Anti-s
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
ORTHO™ Sera Anti-Leb
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
ORTHO™ Sera Anti-Jkb
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
ORTHO™ Sera Anti-D (ORTHO™ Sera Anti-D )
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
Other products from 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
Products from the same license holder (10 products)
20 X Wash Buffer Concentrate
Class B
ORTHO™ Sera Anti-M
Brand: ORTHO™ Sera Anti-P1
Class D
ORTHO™ Sera Anti-Fya
Brand: ORTHO™ Sera Anti-P1
Class D
ORTHO™ Sera Anti-Jka
Brand: ORTHO™ Sera Anti-P1
Class D
ORTHO™ Sera Anti-S
Brand: ORTHO™ Sera Anti-P1
Class D
ORTHO™ Sera Anti-P1
Brand: ORTHO™ Sera Anti-P1
Class D
ORTHO™ Sera Anti-N
Brand: ORTHO™ Sera Anti-P1
Class D
ORTHO™ Sera Anti-s
Brand: ORTHO™ Sera Anti-P1
Class D
ORTHO™ Sera Anti-Leb
Brand: ORTHO™ Sera Anti-P1
Class D
ORTHO™ Sera Anti-Jkb
Brand: ORTHO™ Sera Anti-P1
Class D
About this record

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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