Syphilis Rapid Card Test - India CDSCO Medical Device Registration

Syphilis Rapid Card Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000104_a6c5387441afc0eb06e6ac88c95c0bd6_3f056ac05da32c3e44bef32915d85b26. This device is marketed under the brand name HI-QUIK. The license holder is Helico International, and it is classified as Device Class Class D. The approving authority is Sub Zonal Bangalore.

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CDSCO Registered

Class Class D

Syphilis Rapid Card Test

UID: MFG/IVD/2021/000104_a6c5387441afc0eb06e6ac88c95c0bd6_3f056ac05da32c3e44bef32915d85b26

Brand Name

HI-QUIK

License Holder

Helico International

Device Class

Class D

Approving Authority

Sub Zonal Bangalore

Product Information

The HI-Quik Syphilis Rapid Test Card is a rapid chromatographic immunoassay for the qualitative detection of antibodies (HI-QUIK) to Treponema Pallidum (HI-QUIK) in serum or plasma to aid in the diagnosis of Syphilis.

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Class B