GeneBio HCG Pregnancy Rapid - India CDSCO Medical Device Registration

GeneBio HCG Pregnancy Rapid is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000091_82ffae6d11edd24cd1d33f30085dd57f_ee6dcd2e79ae80203b025ad81932f5b5. This device is marketed under the brand name GeneBio. The license holder is GeneBio Healthare Pvt Ltd, and it is classified as Device Class Class B. The approving authority is Uttar Pradesh.

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

CDSCO Registered

Class Class B

GeneBio HCG Pregnancy Rapid

UID: MFG/IVD/2023/000091_82ffae6d11edd24cd1d33f30085dd57f_ee6dcd2e79ae80203b025ad81932f5b5

Brand Name

GeneBio

License Holder

GeneBio Healthare Pvt Ltd

Device Class

Class B

Approving Authority

Uttar Pradesh

Product Information

hCG Rapid Test is a lateral flow chromatographic immunoassay for the early detection of pregnancy, by providing a quick direct visual test for the placental hormone, hCG in human urine. It can be performed within 5-10 minutes by minimally skilled personnel, and without the use of laboratory equipment. The hCG Rapid Test is not intended for quantitative results, It is intended to meet all requirements for yielding rapid, easily read, qualitative results for the purpose of early pregnancy detection via assay of hCG, a placental hormone that may be present in human urine. The hCG detection limit the hCG Rapid Test is 25 mIU/mL in urine specimen. It is designed for professional use only, and provides only preliminary analytical data. For a final diagnosis of pregnancy, a more specific alternative clinical method must be used to obtain a confirmed analytical result