Panbio Leptospira IgM ELISA - India CDSCO Medical Device Registration

Panbio Leptospira IgM ELISA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000665_416fa2be659de1c9ea553d457dd3bc59_9c898d07f9966a616a5b05be7bfb29c1. 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 Leptospira IgM ELISA

UID: IMP/IVD/2020/000665_416fa2be659de1c9ea553d457dd3bc59_9c898d07f9966a616a5b05be7bfb29c1

Brand Name

SD Urocolor

License Holder

Abbott Diagnostics Medical Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Panbio Leptospira IgM ELISA is for the qualitative detection of IgM antibodies to leptospira in serum as an aid in the clinical laboratory diagnosis of patients with clinical symptoms consistent with leptospirosis