CDSCO UID IMP/IVD/2023/000310_5ddd8ecb910bcdfa017d807b2dd5b417_ba3b01d095bbea45ed6661f57a743c18Lambda free light Chains(Lambda free light Chains)
- UID
- IMP/IVD/2023/000310_5ddd8ecb910bcdfa017d807b2dd5b417_ba3b01d095bbea45ed6661f57a743c18
- Device class
- Class C
- Brand name
- Kappa-lambda FLC control set
- License holder
- Roche Diagnostics India Pvt. Ltd.
- 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
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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