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Real Time PCR - India CDSCO Medical Device Registration

Real Time PCR is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000138_04b45b68511def170b5830617ea78ddc_d558495124f681a3ef2a8196be72f70e. 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
Real Time PCR
UID: MFG/IVD/2020/000138_04b45b68511def170b5830617ea78ddc_d558495124f681a3ef2a8196be72f70e

Brand Name

Concepta D-DIMER Control

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

Concepta COVID 19 Multiplex RT PCR kit is developed for the detection of COVID-19 viral infection by simultaneous tragetting of three major genes ORF1ab, envelope (Concepta D-DIMER Control), and nucleocapsid (Concepta D-DIMER Control). The Kit also includes an internal control to insure successful extraction and amplificatiion of Viral RNA. The Kit is for professional use only

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Brand: Concepta D-DIMER Control

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