Malaria Pf Rapid Test Kit - India CDSCO Medical Device Registration

Malaria Pf Rapid Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000068_6be180f0b8d8891a73de213543ca75ee_9c643095f437ee7e1e54ff6e5aeab61b. This device is marketed under the brand name PathKits Simple COVID-19 Ag Rapid Kit. The license holder is PATHKITS HEALTHCARE PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Sub Zonal Baddi.

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CDSCO Registered

Class Class C

Malaria Pf Rapid Test Kit

UID: MFG/IVD/2021/000068_6be180f0b8d8891a73de213543ca75ee_9c643095f437ee7e1e54ff6e5aeab61b

Brand Name

PathKits Simple COVID-19 Ag Rapid Kit

License Holder

PATHKITS HEALTHCARE PRIVATE LIMITED

Device Class

Class C

Approving Authority

Sub Zonal Baddi

Product Information

The Malaria Pf Rapid Test is a visual, rapid and sensitive solid phase immunochromatographic assay for the qualitative differential detection of P. falciparum (PathKits Simple COVID-19 Ag Rapid Kit) antigen in the blood sample

DJ Fang

MedTech Regulatory Expert

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