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One Step Pregnancy Test Device - India CDSCO Medical Device Registration

One Step Pregnancy Test Device is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000092_998e6434674e1a84cb457fbebf149ace_39735e9918ebb8a19cec868460d83bea. This device is marketed under the brand name INSIGHT AMP. The license holder is CORAL CLINICAL SYSTEMS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is Uttarakhand.

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
One Step Pregnancy Test Device
UID: MFG/IVD/2021/000092_998e6434674e1a84cb457fbebf149ace_39735e9918ebb8a19cec868460d83bea

Brand Name

INSIGHT AMP

Device Class

Class B

Approving Authority

Uttarakhand

Product Information

Tina hCG one step pregnancy test is a rapid, qualitative, two site sandwich immunoassay for the determination of human chorionic gonadotropin (INSIGHT AMP), a marker for pregnancy, in urine specimens

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