CMV Quantitative PCR Kit - India CDSCO Medical Device Registration

CMV Quantitative PCR Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_f199a73c028d5457c84b575996af3dfc_26626e8a37ff799ddfaf3ace6a031a50. This device is marketed under the brand name Multigene-Multiplex Single tube format. The license holder is Mylab Discovery S0lutions Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class C

CMV Quantitative PCR Kit

UID: MFG/IVD/2020/000021_f199a73c028d5457c84b575996af3dfc_26626e8a37ff799ddfaf3ace6a031a50

Brand Name

Multigene-Multiplex Single tube format

License Holder

Mylab Discovery S0lutions Pvt. Ltd

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

PathoDetectTM CMV Quantitative PCR Kit is an in vitro nucleic acid amplification test for the detection and quantification of CMV DNA in human EDTA plasma and EDTA whole blood using real time PCR. PathoDetectTM CMV Quantitative PCR Kit is used as an aid in the management of patients who are undergoing anti-CMV therapy. The assay can be used to measure CMV DNA levels serially at the time infection and during the course of antiviral treatment to assess virological response to treatment. The test results must be interpreted within the context of all relevant clinical and laboratory findings

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Phenylalanine Detection Test

Brand: Multigene-Multiplex Single tube format

Mylab Discovery S0lutions Pvt. Ltd

CMV Quantitative PCR Kit - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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