Lambda free light Chains(Lambda free light Chains) - India CDSCO Medical Device Registration
Lambda free light Chains(Lambda free light Chains) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000310_5ddd8ecb910bcdfa017d807b2dd5b417_ba3b01d095bbea45ed6661f57a743c18. 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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Brand Name
Kappa-lambda FLC control set
License Holder
Roche Diagnostics India Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
The Diazyme Human Lambda (Kappa-lambda FLC control set) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (Kappa-lambda FLC control set) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis of multiple myeloma in conjunction with other laboratory findings. For in vitro diagnostic use only
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