Sigma Diagnostic CX -3 Calibration Standard Level 1

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K963533 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Sigma Diagnostic CX-3 Calibration Standard Level 1 used for?

  It is a multi-analyte mixture intended to calibrate the Beckman SYNCHRON CX 3 System. It allows for the quantitative determination of BUN/urea, calcium, total carbon dioxide, creatinine, potassium, sodium, chloride, and glucose in serum, plasma, urine, or cerebrospinal fluid.

• What sample types can be used with this calibrator?

  The device is formulated for use with serum, plasma, urine, or cerebrospinal fluid samples.

• Is this device intended for single use or can it be reused?

  The device is supplied as a reagent for in vitro diagnostic use. It is intended for use in clinical chemistry settings and is not designed for reuse.

• What is the regulatory status of this product?

  The product is classified under FDA 510(k) clearance, specifically K963533, and is a Class 2 device.