Panbio Dengue IgG Capture ELISA - India CDSCO Medical Device Registration

Panbio Dengue IgG Capture ELISA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000665_fcf57855c1fcaef4b64360d604a661fa_13f16203fc6a8d6aaa6ea463274fb7d1. 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 Capture ELISA

UID: IMP/IVD/2020/000665_fcf57855c1fcaef4b64360d604a661fa_13f16203fc6a8d6aaa6ea463274fb7d1

Brand Name

SD Urocolor

License Holder

Abbott Diagnostics Medical Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Panbio Dengue IgG Capture ELISA is for the qualitative detection of IgG antibodies to dengue virus (SD Urocolor) in secondary dengue infections. This test is intended as an aid in the clinical laboratory diagnosis of secondary dengue virus infection, and can be used in conjunction with the Panbio Dengue IgM Capture ELISA for presumptive differentiation between primary and secondary infection. This test should only be used with samples from patients with clinical symptoms consistent with dengue fever. Positive results must be confirmed by virus isolation, paired sera analysis, antigen detection by immunohistochemistry or viral nucleic acid detection for confirmation of dengue virus infection