2019- nCoV Antigen Test - India CDSCO Medical Device Registration
2019- nCoV Antigen Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000297_642a8c073cbb7f2ce47cb4e31c206d9c_6a495173408e0195f75ae4dc9f7f1099. This device is marketed under the brand name Wondfo. The license holder is INVEX HEALTH PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Wondfo
License Holder
INVEX HEALTH PRIVATE LIMITEDDevice Class
Approving Authority
CDSCO
Product Information
Wondfo 2019-nCoV Antigen Test (Wondfo) is an immunochromatographic assay for rapid, qualitative detection of novel coronavirus (Wondfo) antigen extracted from the nasopharyngeal swab or oropharyngeal swab specimen. The test is to be used as an aid for the diagnosis of coronavirus infection disease (Wondfo), which is caused by 2019-nCoV. The test may be used by professionals in laboratory and non-laboratory settings.the test provides preliminary test results. Negative results can not exclude 2019-nCov infection and they cannot be used as the sole basis for treatment or other management decision. For in vitro diagnostic use only.
