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BCR-ABL IS RQ-PCR - India CDSCO Medical Device Registration

BCR-ABL IS RQ-PCR is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000138_515391c8e07366ede4b0c75a2ad7c56f_5f249d0755a1ea588419f634ced68c54. This device is marketed under the brand name Concepta D-DIMER Control. The license holder is BIOSYSTEMS DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.

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
BCR-ABL IS RQ-PCR
UID: MFG/IVD/2020/000138_515391c8e07366ede4b0c75a2ad7c56f_5f249d0755a1ea588419f634ced68c54

Brand Name

Concepta D-DIMER Control

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

The GenePath Dx BCR-ABL test kit is intended for the detection and quantification of the BCR-ABL and ABL transcripts

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