Dengue NS1 Ag - India CDSCO Medical Device Registration

Dengue NS1 Ag is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000203_7d5bf1f2420312cd00c53fc7d328c646_28b8b3f7dcf93e27c665fe67b617e5be. This device is marketed under the brand name QDx Instacheck™ AFP. The license holder is DiaSys Diagnostics India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Dengue NS1 Ag

UID: IMP/MD/2018/000203_7d5bf1f2420312cd00c53fc7d328c646_28b8b3f7dcf93e27c665fe67b617e5be

Brand Name

QDx Instacheck™ AFP

License Holder

DiaSys Diagnostics India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

QDx Instacheck™ Dengue NS1 Ag is a fluorescence Immunoassay (QDx Instacheck™ AFP) for the qualitative determination of NS1 Ag in human whole blood/serum/plasma during dengue virus infection. It is useful as an aid in screening of early Dengue virus infection. For in vitro diagnostic use only

Class C

Dengue IgG/IgM

Brand: QDx Instacheck™ AFP

DiaSys Diagnostics India Private Limited

Class C

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Dengue NS1 Ag - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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