Pure Global

Luteinizing Hormone Rapid Test Device - India CDSCO Medical Device Registration

Luteinizing Hormone Rapid Test Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000087_6d1959fe4b8d9711e6426c6d4a1eaabf_2d1ca9d954e28bde59ad26a8fab1bc62. This device is marketed under the brand name Urine/Serum. The license holder is SR Bioera Private Limited., and it is classified as Device Class Class B. The approving authority is Gujarat.

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
Luteinizing Hormone Rapid Test Device
UID: MFG/IVD/2022/000087_6d1959fe4b8d9711e6426c6d4a1eaabf_2d1ca9d954e28bde59ad26a8fab1bc62

Brand Name

Urine/Serum

Device Class

Class B

Approving Authority

Gujarat

Product Information

A Luteinizing Hormone (Urine/Serum) Rapid Test is a rapid and convenient immunochromatographic assay for the qualitative detection of LH in urine at or above the concentration of 30 mIU/ml and predicting the time of LH surge and ovulation. The device is designed for professional as well as over the counter use. The test provides a visual, qualitative result. Clinical expertise and professional judgment should be sought to further evaluate the result of the test

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing