VISITECT CD4 - India CDSCO Medical Device Registration

VISITECT CD4 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2018/000005_ec00bb92ff0d4245dc343c83537bc3f8_e1ea23b093607e2b6d5169348883c762. This device is marketed under the brand name Pathozyme® Ovarian Cancer Antigen Ag 125 ELISA. The license holder is Omega DX (Asia) 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

VISITECT CD4

UID: IMP/IVD/2018/000005_ec00bb92ff0d4245dc343c83537bc3f8_e1ea23b093607e2b6d5169348883c762

Brand Name

Pathozyme® Ovarian Cancer Antigen Ag 125 ELISA

License Holder

Omega DX (Asia) Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

The VISTECT CD4 Rapid Test is a semi-quantitative assay for the estimation of CD4 protein on the surface of CD4+ T cells in human whole bood to indicate whether the level is above or below 350 cells/uL within pre-diagnosed HIV patients

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