Total P1NP CalSet - India CDSCO Medical Device Registration
Total P1NP CalSet is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000038_fae9ac6d882e0d25396a4c79bd7f1f92_6190313e18a476c34eba1aa79508698f. This device is marketed under the brand name Antithrombin. The license holder is Roche Diagnostics India Pvt. Ltd., and it is classified as Device Class Class C. 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.
Brand Name
Antithrombin
License Holder
Roche Diagnostics India Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
Total P1NP CalSet is used for calibrating the quantitative Elecsys total P1NP assay on the Elecsys and cobas e immunoassay analyzers
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