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/2020/000255_5b13e39dd159a6f75b63c2f8306d4824_6a410c732b45f20b972ae51e7c900a73. This device is marketed under the brand name Colloidal Gold Immunochromatography. 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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CDSCO Registered

Class Class C

SARS-CoV-2 Antibody Test

UID: IMP/IVD/2020/000255_5b13e39dd159a6f75b63c2f8306d4824_6a410c732b45f20b972ae51e7c900a73

Brand Name

Colloidal Gold Immunochromatography

License Holder

Trivitron Healthcare Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The product is intended for the qualitative detection of antibody content against COVID-19 in clinical samples (Colloidal Gold Immunochromatography).

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