SARS-CoV-2 Antibody Test
- UID
- IMP/IVD/2020/000323_5b13e39dd159a6f75b63c2f8306d4824_09edac80561c158b2a3cb72c7e013a81
- Device class
- Class C
- Brand name
- Lateral Flow Method
- License holder
- Trivitron Healthcare Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method) is an immunochromatographic assay for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (Lateral Flow Method) IgG/IgM antibody in human whole blood, serum or plasma sample. The test is to be used as an aid in the diagnosis of coronavirus infection disease (Lateral Flow Method), which is caused by SARS-CoV-2.
SARS-CoV-2 Antibody Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000323_5b13e39dd159a6f75b63c2f8306d4824_09edac80561c158b2a3cb72c7e013a81. This device is marketed under the brand name Lateral Flow Method. The license holder is Trivitron Healthcare Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.
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