Panbio Dengue IgG Indirect ELISA - India CDSCO Medical Device Registration

Panbio Dengue IgG Indirect ELISA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000665_255ecbaf2414ca5cecd5e7d3f66c7bc0_2880c0d8f52c3fc0df9ecb4cb4f9a721. 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 IgG Indirect ELISA

UID: IMP/IVD/2020/000665_255ecbaf2414ca5cecd5e7d3f66c7bc0_2880c0d8f52c3fc0df9ecb4cb4f9a721

Brand Name

SD Urocolor

License Holder

Abbott Diagnostics Medical Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Panbio Dengue IgG Indirect ELISA is for qualitative detection of IgG antibodies to dengue antigen serotypes (SD Urocolor) in serum, as an aid in the clinical laboratory diagnosis of patients with clinical symptoms and past exposure consistent with dengue fever.