SARS-CoV-2 Antibody Test
- UID
- IMP/IVD/2020/000329_b15aab46799c3fae1b16f09c3d5d39c9_f31cc4903c6740661e2eff6661c711ff
- Device class
- Class C
- Brand name
- Lateral Flow Method
- License holder
- Core Diagnostics Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- This product 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. The test provides preliminary test results. Negative results don’t preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decision.
SARS-CoV-2 Antibody Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000329_b15aab46799c3fae1b16f09c3d5d39c9_f31cc4903c6740661e2eff6661c711ff. This device is marketed under the brand name Lateral Flow Method. The license holder is Core Diagnostics Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.
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