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CDSCO UID MFG/IVD/2020/000138_cfb0687b72689f34fb0009d0e3fcd523_c20f4301e1f21fe7093c7f1f5ac23567

Cytomegalovirus qPCR Test Kit

BIOSYSTEMS DIAGNOSTICS PRIVATE LIMITED·Device Class Class C·India CDSCO·Brand: Concepta D-DIMER Control
Registration details
UID
MFG/IVD/2020/000138_cfb0687b72689f34fb0009d0e3fcd523_c20f4301e1f21fe7093c7f1f5ac23567
Device class
Class C
Brand name
Concepta D-DIMER Control
License holder
BIOSYSTEMS DIAGNOSTICS PRIVATE LIMITED
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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About this record

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.

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