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.
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Brand Name
Pf-HRPII/PAN-pLDH
License Holder
Oxalis Diagnostics Pvt. LtdDevice Class
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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