Human Chorionic Gonadotropin test kits - India CDSCO Medical Device Registration

Human Chorionic Gonadotropin test kits is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000017_129c3d69494553448ded181066046b5f_aab808ec2d34842af50ef004b2251f87. This device is marketed under the brand name Standard F TSH FIA. The license holder is SD Biosensor Healthcare Pvt. Ltd, and it is classified as Device Class Class B. The approving authority is Haryana.

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CDSCO Registered

Class Class B

Human Chorionic Gonadotropin test kits

UID: MFG/IVD/2020/000017_129c3d69494553448ded181066046b5f_aab808ec2d34842af50ef004b2251f87

Brand Name

Standard F TSH FIA

License Holder

SD Biosensor Healthcare Pvt. Ltd

Device Class

Class B

Approving Authority

Haryana

Product Information

ULTRA hCG is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadtropin (Standard F TSH FIA) in urine to aid in the early detection of pregnancy. The test is intended for in vitro diagnostics self-testing. The test has a detection limit of 10mIU/ml or greater concentration of hCG in urine