A Real Time RT-PCR Duplex Test for detection of Dengue and Chikungunya Virus - India CDSCO Medical Device Registration

A Real Time RT-PCR Duplex Test for detection of Dengue and Chikungunya Virus is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000134_734d7311362e39fa8fccd0e627656f4c_2f821315fc14a39ca628f40c136fd3c8. This device is marketed under the brand name AMPLICHAIN Dengue/Chik V. The license holder is TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Sub Zonal Goa.

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CDSCO Registered

Class Class C

A Real Time RT-PCR Duplex Test for detection of Dengue and Chikungunya Virus

UID: MFG/IVD/2022/000134_734d7311362e39fa8fccd0e627656f4c_2f821315fc14a39ca628f40c136fd3c8

Brand Name

AMPLICHAIN Dengue/Chik V

License Holder

TULIP DIAGNOSTICS PRIVATE LIMITED

Device Class

Class C

Approving Authority

Sub Zonal Goa

Product Information

RT-PCR in-vitro diagnostic test kit intended for the qualitative detection of dengue virus serotype (AMPLICHAIN Dengue/Chik V) and Chikungunya virus from the clinical sample like blood/serum/plasma in humans collected from individual suspected of dengue or Chikungunya infection by their healthcare provider