Panbio Dengue IgM Capture ELISA - India CDSCO Medical Device Registration

Panbio Dengue IgM Capture ELISA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000665_9a0f246f233dee0fe44719448fd3e22f_a740962514b31be8877fb2080374ddef. This device is marketed under the brand name SD Urocolor. The license holder is Abbott Diagnostics Medical Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Panbio Dengue IgM Capture ELISA

UID: IMP/IVD/2020/000665_9a0f246f233dee0fe44719448fd3e22f_a740962514b31be8877fb2080374ddef

Brand Name

SD Urocolor

License Holder

Abbott Diagnostics Medical Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Panbio Dengue IgM Capture ELISA is for the qualitative detection of IgM antibodies to dengue antigen in serum as an aid in the clinical laboratory diagnosis of patients with clinical symptoms consistent with dengue fever. The Panbio Dengue IgM Capture ELISA should be used in conjunction with other dengue serology