One Step Dengue IgM-IgG Rapid test - India CDSCO Medical Device Registration

One Step Dengue IgM-IgG Rapid test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000017_db446ddbefcbb4dfd1bc265ccadf1bd2_a3056a27883a6fb39bfbbbc07e620a69. This device is marketed under the brand name Standard F TSH FIA. The license holder is SD Biosensor Healthcare Pvt. Ltd, and it is classified as Device Class Class B. The approving authority is Haryana.

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CDSCO Registered

Class Class B

One Step Dengue IgM-IgG Rapid test

UID: MFG/IVD/2020/000017_db446ddbefcbb4dfd1bc265ccadf1bd2_a3056a27883a6fb39bfbbbc07e620a69

Brand Name

Standard F TSH FIA

License Holder

SD Biosensor Healthcare Pvt. Ltd

Device Class

Class B

Approving Authority

Haryana

Product Information

It is an immunochromatographic assay for the detection IgM/IgG antibodies against Dengue virus in human serum, plasma or whole blood specimen

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