LEPTOSPIRA Antibody Test - India CDSCO Medical Device Registration
LEPTOSPIRA Antibody Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000103_fc5550752fd0ff0f571dc14d48ca3d87_b828054577036db3adf71a0807c51be8. The license holder is Genovik Biotech Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Rajasthan.
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License Holder
Genovik Biotech Pvt. Ltd.Device Class
Approving Authority
Rajasthan
Product Information
Genovik Leptospira Antibody Test is a simple immunochromatographic test that utilizes antigens from L. interrogans to detect and discriminate IgG and IgM antibodies to Leptospira. The test can be performed within 15-20 minutes by minimally skilled personnel without the use of laboratory equipment
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