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Rapid Dengue NS1 Ag Test - India CDSCO Medical Device Registration

Rapid Dengue NS1 Ag Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000068_f9b18e07dac91f3602fe85ca51fdd865_631ffbf573bf68eb56abc17a087b3489. This device is marketed under the brand name Pf-HRPII/PAN-pLDH. The license holder is Oxalis Diagnostics Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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
Rapid Dengue NS1 Ag Test
UID: MFG/IVD/2022/000068_f9b18e07dac91f3602fe85ca51fdd865_631ffbf573bf68eb56abc17a087b3489

Brand Name

Pf-HRPII/PAN-pLDH

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

Rapid Dengue NS1 Ag test is a lateral flow chromatographic immunoassay for the detection of Dengue NS1 antigen in human blood/serum/plasma. It is intended to be used by healthcare professionals to aid in the diagnosis of infection with dengue virus. Alternative test method(Pf-HRPII/PAN-pLDH) should be considered to confirm the test result obtained by this device.

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DJ Fang

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