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One Step COVID-19 Antigen Test - India CDSCO Medical Device Registration

One Step COVID-19 Antigen Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000005_d869de5278cf25a6e74e3ad2be9e4b34_f9d8c90d1d18ee41f747aabe5d4d8795. This device is marketed under the brand name STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test. The license holder is SD Biosensor Healthcare Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is Sub Zonal Baddi.

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 C
One Step COVID-19 Antigen Test
UID: MFG/MD/2018/000005_d869de5278cf25a6e74e3ad2be9e4b34_f9d8c90d1d18ee41f747aabe5d4d8795

Brand Name

STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test

Device Class

Class C

Approving Authority

Sub Zonal Baddi

Product Information

ULTRA COVID-19 Ag Test is a rapid immunochromatographic assay for the qualitative detection of specific antigens to SARS-CoV-2 present in human nasopharynx

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