Kappa-lambda FLC control set - India CDSCO Medical Device Registration
Kappa-lambda FLC control set is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000310_ff85f19d2efd9e8793f4480c78699edb_6bfd24e17245edd49e6cdb4e11de478a. 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
Kappa ‑ Lambda FLC Control Set is intended for use in monitoring the quality control of results obtained with the Kappa (Kappa-lambda FLC control set) and Lambda (Kappa-lambda FLC control set) Free Light Chains Assay. For in‑vitro diagnostic use only
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