Vitamin B 12 ELISA Test Kit - India CDSCO Medical Device Registration
Vitamin B 12 ELISA Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000073_c87da22b0bca34b360e776437f8ae228_18cbb914e9331195b9d3a2f560508a96. The license holder is Weldon Biotech India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Uttarakhand.
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.
License Holder
Weldon Biotech India Pvt. Ltd.Device Class
Approving Authority
Uttarakhand
Product Information
With the advent and easy availability of vitamins and minerals determination of Vitamin B-12 in the circulation has gained considerable scrutiny. . Most common causes of Vitamin B-12 deficiency include diet and age. Useful tests to distinguish between Vitamin B-12 and Folate deficiency are methylmalonyl CoA (NA) and homocysteine (NA). Both manifest in similar symptoms; however even though both show increased levels of hcy only Vitamin B-12 deficiency causes increased levels of methylmalonyl CoA. . Deficiency of Vitamin B-12 causes increased levels of hcy and MMA that are deemed to be responsible for oxidative stress that can cause coronary heart disease, atherosclerosis and neurodegenerative conditions like Parkinsonโs. Vitamin B-12 can be assayed in the range of 200 โ 840 pg/ml using 50 ฮผl serum samples

