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Rapid Dengue IgG/IgM Test - India CDSCO Medical Device Registration

Rapid Dengue IgG/IgM Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000037_fb3131280afab2bac63b5ea3fff34b1b_297ceb52533d40c23a576381b85a4cd4. This device is marketed under the brand name Urine. The license holder is Oxalis Diagnostics Pvt. Ltd, and it is classified as Device Class Class B. The approving authority is Pune Division.

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CDSCO Registered
Class Class B
Rapid Dengue IgG/IgM Test
UID: MFG/IVD/2022/000037_fb3131280afab2bac63b5ea3fff34b1b_297ceb52533d40c23a576381b85a4cd4

Brand Name

Urine

Device Class

Class B

Approving Authority

Pune Division

Product Information

Rapid Dengue IgG/IgM test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of anti-dengue virus IgG, IgM 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(Urine) should be considered to confirm the test result obtained by this device

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