Dengue NS1Ag - India CDSCO Medical Device Registration

Dengue NS1Ag is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000055_6f4737525fd447770a368411b4ec02fc_ea96e980e8b442c9b5034ff6d1df4b5b. This device is marketed under the brand name RAPHA SERO. The license holder is M/s Rapha Diagnostics PVt. Ltd.,, and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered

Class Class C

Dengue NS1Ag

UID: MFG/IVD/2021/000055_6f4737525fd447770a368411b4ec02fc_ea96e980e8b442c9b5034ff6d1df4b5b

Brand Name

RAPHA SERO

License Holder

M/s Rapha Diagnostics PVt. Ltd.,

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

N'SURE Dengue NS1Ag is a rapid, qualitative immunochromatographic assay for the detection of dengue virus NS1 antigen in human serum or plasma. The N'SURE Dengue NS1Ag Rapid Test is only intended for initial screening and reactive samples should be confirmed by a supplemental assay such as IgG/IgM ELISA, RT-PCR or HI (RAPHA SERO) test.This is an In vitro diagnostic test for professional use only

Class C

Brand: SECURE

Class B