DIAZO-CHEK

Biorex Labs LLC · Model 1 · UDI-DI 00860009154018

510(k) clearances

Adverse events

Recalls

Facilities

Description

The DIAZO-CHEK test is used to qualitatively detect bilirubin in urine or confirm the positive results obtained by a reagent strip. The Test is intended for use by the appropriately trained laboratory professionals. The test consists of Reagent discs and the test pads which bind the bilirubin from a Urine specimen. The test is based on the diazo coupling reaction between the adsorbed bilirubin and a stabilized diazonium salt of Nitrobenzene. The reaction results in the development of varying grades of purple to bluish-purple color which is easily visible by the naked eye.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.