Malaria Pf/PAN Antigen Test - India CDSCO Medical Device Registration

Malaria Pf/PAN Antigen Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000021_3dbc883d959c2f0c7807ef6d66f5d61d_7c67aac07fb3e415e727ca7467acfe6c. 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

Malaria Pf/PAN Antigen Test

UID: MFG/IVD/2020/000021_3dbc883d959c2f0c7807ef6d66f5d61d_7c67aac07fb3e415e727ca7467acfe6c

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

Malaria Pf/Pan Antigen Test is intended for the qualitative detection of P. falciparum specific Histidine rich protein-2 (Multigene-Multiplex Single tube format) and PAN malaria specific pLDH for screening and diagnosis of malaria from human blood (Multigene-Multiplex Single tube format). Also, differential diagnosis between P. falciparum and other malarial species. Malaria Pf/Pan Test is intended to be used by trained healthcare or other healthcare workers as well as for self-testing

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Malaria Pf/PAN Antigen Test

Brand: PathoCatch

M/s Mylab Discovery Solutions Pvt. Ltd.

Malaria Pf/PAN Antigen Test - India CDSCO Medical Device Registration

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License Holder

Device Class

Approving Authority

Product Information

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