Kappa free light Chains(Kappa free light Chains) - India CDSCO Medical Device Registration

Kappa free light Chains(Kappa free light Chains) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000310_048e3b912e902e11eba93b7beece8cce_5ffc16b171db326aba5967caaa57baa3. This device is marketed under the brand name Kappa-lambda FLC control set. The license holder is Roche Diagnostics India Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Kappa free light Chains(Kappa free light Chains)

UID: IMP/IVD/2023/000310_048e3b912e902e11eba93b7beece8cce_5ffc16b171db326aba5967caaa57baa3

Brand Name

Kappa-lambda FLC control set

License Holder

Roche Diagnostics India Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Diazyme Human Kappa (Kappa-lambda FLC control set) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (Kappa-lambda FLC control set) concentration in serum on validated analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis of multiple myeloma in conjunction with other laboratory findings. For in vitro diagnostic use only.