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PSA Rapid Test - India CDSCO Medical Device Registration

PSA Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000139_4c439a63bff465047159bb126b8bc9c8_a8636213af5a07ef53279ef8f234277e. This device is marketed under the brand name Prostate Specific Antigen. The license holder is LABGENE BIO-TECH PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class C
PSA Rapid Test
UID: MFG/IVD/2022/000139_4c439a63bff465047159bb126b8bc9c8_a8636213af5a07ef53279ef8f234277e

Brand Name

Prostate Specific Antigen

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

The PSA Rapid test kit is a rapid immunochromatography assay for the semi-quantitative detection of Prostate Specific Antigen (Prostate Specific Antigen) in human whole blood, serum or plasma samples

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