MTB RIF & INH Resistance Detection Kit - India CDSCO Medical Device Registration

MTB RIF & INH Resistance Detection Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_422abef416d10f5b27bfe7b1caa65d74_0f18b15af5ffe13ffb2dc64240248c40. 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

MTB RIF & INH Resistance Detection Kit

UID: MFG/IVD/2020/000021_422abef416d10f5b27bfe7b1caa65d74_0f18b15af5ffe13ffb2dc64240248c40

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 MTB RIF & INH Resistance Detection Kit is a multiplex real time PCR test intended for the simultaneous in vitro qualitative detection of Mycobacterium tuberculosis complex (Multigene-Multiplex Single tube format) and its resistance to Rifampicin and Isoniazid antibiotics from the clinical specimens collected from the suspected individuals by the health care provider. PathoDetectTM MTB RIF &INH Resistance Detection Kit is only intended to detect the MTB complex and its drug resistance to Rifampicin and Isoniazid and does not apply to other pathogens or antibiotic resistance genes that may be present in the human clinical samples. The positive results are indicative of an active infection but do not rule out the infection or coinfection with other pathogens not detected by the test

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Brand: Multigene-Multiplex Single tube format

Mylab Discovery S0lutions Pvt. Ltd

MTB RIF & INH Resistance Detection Kit - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

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