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/2022/000018_a66774ea0d52680253724ee79983a338_7cbc4d7491bb7e51d92883c2ef7e5414. This device is marketed under the brand name PT. The license holder is Beacon Diagnostics Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class C

Malaria PF/PAN antigen test

UID: MFG/IVD/2022/000018_a66774ea0d52680253724ee79983a338_7cbc4d7491bb7e51d92883c2ef7e5414

Brand Name

License Holder

Beacon Diagnostics Pvt. Ltd.

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

For Simultaneous and differential detection of Pan LDH antigen of plasmodium vivax, plasmodium falciparum, plasmodium ovale and plasmodium malaria and plasmodium falciparum HRP-II, in human whole blood