Cyclosporine Extended Range Assay (CSAE) Flex Reagent Cartridge, Catalog # DF108

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K052017 ↗

FDA Product Code

MKW

Device Class

Class II

Regulation

21 CFR Part 862.1235

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Dade Behring, Inc. →

• What is the Cyclosporine Extended Range Assay (CSAE) Flex Reagent Cartridge used for?

  It is designed to measure cyclosporine levels in patient samples when used on the Dade Behring Dimension® clinical chemistry system, providing an in vitro diagnostic tool for therapeutic drug monitoring in clinical laboratory settings.

• How is the CSAE Flex Reagent Cartridge supplied and is it sterile or single-use?

  The cartridge is supplied as a single-use, non-sterile device containing prepackaged reagents in a plastic eight-well cartridge, intended for one-time use only in clinical laboratories to prevent cross-contamination and ensure consistent reagent performance.

• What regulatory authorization does the CSAE Flex Reagent Cartridge have and what is its classification?

  It is authorized under FDA 510(k) clearance K052017 and classified as a Class II medical device under regulation number 862.1235 with product code MKW, indicating it is substantially equivalent to a legally marketed predicate device for clinical chemistry applications.