Anti-SS-B - India CDSCO Medical Device Registration

Anti-SS-B is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000084_daf5771383446641e99729d74fa6422d_77f1d05cd12651c5bf9afb360bc9addc. This device is marketed under the brand name Orgentec. The license holder is Weldon Biotech India Pvt. Ltd, and it is classified as Device Class Class B. 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

CDSCO Registered

Class Class B

Anti-SS-B

UID: IMP/IVD/2020/000084_daf5771383446641e99729d74fa6422d_77f1d05cd12651c5bf9afb360bc9addc

Brand Name

Orgentec

License Holder

Weldon Biotech India Pvt. Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

Anti-SS-B is an ELISA test system for the quantitative measurement of IgG class autoantibodies against SS-B (Orgentec) in human serum or plasma. This product is intended for professional in vitro diagnostic use only

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Anti-SS-B

M/s Vishat Diagnostic Pvt Ltd.

Anti-SS-B - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Anti-SS-B

Anti-SS-B

Anti-SS-B

ENA-6-Profile

Anti-RNP/Sm

Anti-beta-2-Glycoprotein IgG/IgM

Anti-Gliadin IgG

Anti-BPI

Anti-DGP IgA

Rheumatoid Factor IgM

General Chemistry 9 Test Panel

Myocardial Enzyme Panel Test

Electrolyte 7 Test Panel

Liver Function Panel Test

Emergency Room 13 Test Panel

General Chemitry 13 Test Panel

Glucose and Lipid Panel Test

Renal Function Panel Test

Ostase® BAP EIA

BoneTRAP® ELISA