Covid-19, Antigen Test - India CDSCO Medical Device Registration

Covid-19, Antigen Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000131_78526c696f2c907b19d8dc9cce77076c_ff2497db0fe50e82d1ca02ed595a6342. This device is marketed under the brand name Nanz Comfort ® Malaria Antigen P.f/ P.v Test. The license holder is NANZ MED SCIENCE PHARMA 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

Covid-19, Antigen Test

UID: MFG/IVD/2022/000131_78526c696f2c907b19d8dc9cce77076c_ff2497db0fe50e82d1ca02ed595a6342

Brand Name

Nanz Comfort ® Malaria Antigen P.f/ P.v Test

License Holder

NANZ MED SCIENCE PHARMA PRIVATE LIMITED

Device Class

Class C

Approving Authority

Sub Zonal Baddi

Product Information

COVID-19 Antigen Test is a rapid and convenient immunochromatographic assay for the qualitative detection of COVID-19 antigen (Nanz Comfort ® Malaria Antigen P.f/ P.v Test) from nasopharyngeal swab obtained from patient with signs and symptoms of respiratory infection. This test is for administration by healthcare workers and labs only, as an aid to early diagnosis of SARS-CoV-2 infection in-patient with clinical symptoms of SARS-CoV-2 infection