Pure Global

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

ORTHO™ Sera Anti-Leb is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000042_7a22b459134c7118374b015ff27c243a_2081b389980dbf87b0c36b878f8026d9. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class D
ORTHO™ Sera Anti-Leb
UID: IMP/MD/2018/000042_7a22b459134c7118374b015ff27c243a_2081b389980dbf87b0c36b878f8026d9

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

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Similar Products (10)
Other products with the same name or brand

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

Class D

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

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-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-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-Fyb

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