Pregnancy Test - India CDSCO Medical Device Registration

Pregnancy Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000125_332763543baeb160173eb1e8ef5eeb60_f855955e6339c2fcc740e7be78e68a6e. This device is marketed under the brand name Dr. Morepen. The license holder is Morepen Laboratories Ltd., and it is classified as Device Class Class B. The approving authority is Solan(BBN).

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CDSCO Registered

Class Class B

Pregnancy Test

UID: MFG/IVD/2021/000125_332763543baeb160173eb1e8ef5eeb60_f855955e6339c2fcc740e7be78e68a6e

Brand Name

Dr. Morepen

License Holder

Morepen Laboratories Ltd.

Device Class

Class B

Approving Authority

Solan(BBN)

Product Information

The Dr. Morepen Pregnancy Test HCG-01 is a rapid, self-performing, two site sandwich immunoassay test intended for the qualitative detection of β human chorionic gonadotropin (Dr. Morepen) in human urine samples. It is intended to be used by patients or Healthcare Professionals as a screening test for pregnancy. It is intended for use outside of the body (Dr. Morepen).