SARS-CoV-2 Antibody Test - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class C

SARS-CoV-2 Antibody Test

UID: IMP/IVD/2020/000329_b15aab46799c3fae1b16f09c3d5d39c9_f31cc4903c6740661e2eff6661c711ff

Brand Name

Lateral Flow Method

License Holder

Core Diagnostics Pvt. Ltd.

Device Class

Class C

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.