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Cytomegalovirus qPCR Test Kit - India CDSCO Medical Device Registration

Cytomegalovirus qPCR Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000138_cfb0687b72689f34fb0009d0e3fcd523_c20f4301e1f21fe7093c7f1f5ac23567. 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
Cytomegalovirus qPCR Test Kit
UID: MFG/IVD/2020/000138_cfb0687b72689f34fb0009d0e3fcd523_c20f4301e1f21fe7093c7f1f5ac23567

Brand Name

Concepta D-DIMER Control

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

The GenePath Dx CMV assay is intended for viral load quantification to aid in the management of patients who have undergone solid organ transplant, undergoing anti-CMV therapy, patients on immuno-suppressants or with leukemia, eye infections and neonatal CMV

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