Pure Global

Vitamin B 12 Estimation Kit - India CDSCO Medical Device Registration

Vitamin B 12 Estimation Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2019/000030_d61f13d9febe8cb16d772a3f4247e92e_bf03100d185a1f054d08d7c425b96ba9. This device is marketed under the brand name Total & Direct. The license holder is PROTON BIOLOGICALS INDIA PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is Karnataka.

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 B
Vitamin B 12 Estimation Kit
UID: MFG/IVD/2019/000030_d61f13d9febe8cb16d772a3f4247e92e_bf03100d185a1f054d08d7c425b96ba9

Brand Name

Total & Direct

Device Class

Class B

Approving Authority

Karnataka

Product Information

Active-B12 (Total & Direct) assay is an enzyme-immunoassay (Total & Direct) for the quantitative determination of holotranscobalamin (Total & Direct) in human serum. HoloTC (Total & Direct) is used as an aid in the diagnosis and treatment of vitamin B deficiency

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing