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Ultra Sensitive TSH ELISA - India CDSCO Medical Device Registration

Ultra Sensitive TSH ELISA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000005_bc9eec51f1b0b64d5f8852c717c93797_e4d94e6ea04883012110f8fe7d545aaa. This device is marketed under the brand name Pathozyme® Ultrasensitive TSH. The license holder is Omega DX (Asia) Private Limited, 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.

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CDSCO Registered
Class Class B
Ultra Sensitive TSH ELISA
UID: IMP/IVD/2018/000005_bc9eec51f1b0b64d5f8852c717c93797_e4d94e6ea04883012110f8fe7d545aaa

Brand Name

Pathozyme® Ultrasensitive TSH

Device Class

Class B

Approving Authority

CDSCO

Product Information

Pathozyme® Ultrasensitive TSH is an in-vitro diagnostic kit used for the quantitative determination of Thyroid Stimulating Hormone (Pathozyme® Ultrasensitive TSH) in human serum with a sensitivity of 0.05 uIU/ml

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