2019-nCoV Ab Test - India CDSCO Medical Device Registration
2019-nCoV Ab Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000306_d67b4af96567680f60c6e6039a17af88_c3d74579b08be0d2b589da318944b7b6. This device is marketed under the brand name Colloidal Gold. 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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Brand Name
Colloidal Gold
License Holder
Trivitron Healthcare Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
The kit is intended for the qualitative detection of IgM and IgG antibodies against 2019 Novel Coronavirus (Colloidal Gold) in human serum/plasma/venous whole blood specimen and for the Auxiliary diagnosis of 2019-nCoV infection.
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