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The Diazyme Human Kappa (κ) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis and monitoring of multiple myeloma and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS) in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.

The Diazyme Human Lambda (λ) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis and monitoring of multiple myeloma and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS) in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.

No modification is made to the kit components for the Diazyme Human Kappa (κ) and Lambda (λ) Free Light Chain Assays cleared in K153394.

The Diazyme Human Kappa (κ) Free Light Chain Assay is comprised of the following reagents:

• Reagent R1: Tris buffer solution
• Reagent R2: Carboxyl Polystyrene particles coated with polyclonal rabbit and goat anti-Kappa FLC antibodies
• Calibrators: A five-level set in liquid form (5 x 1 mL)

Material required but not provided

• Controls Set: Two levels, serum based, liquid form

The Diazyme Human Lambda (λ) Free Light Chain Assay is comprised of the following reagents:

• Reagent R1: Tris buffer solution
• Reagent R2: Carboxyl Polystyrene particles coated with polyclonal rabbit anti-Lambda FLC antibodies
• Calibrators: A five-level set in liquid form (5 x 1 mL)

Material required but not provided

• Controls Set: Two levels, serum based, liquid form

N/A

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