Bilirubin-SL (Direct) Assay Catalogue Number 247-10, 247-30

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K981609 ↗

FDA Product Code

CIG

FDA applicant

Diagnostic Chemicals , Ltd.

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Diagnostic Chemicals, Ltd. →

• What is the Bilirubin-SL (Direct) Assay used for?

  The Bilirubin-SL (Direct) Assay is used for the quantitative measurement of direct (conjugated) bilirubin in serum samples. It enables clinical laboratories to assess liver function and detect conditions such as obstructive jaundice or hepatocellular disease by measuring the concentration of bilirubin that is already conjugated in the blood.

• How is the Bilirubin-SL (Direct) Assay supplied and what are its catalogue numbers?

  The assay is supplied as a reagent kit containing the necessary chemicals for the diazo colorimetric reaction. It is available under two catalogue numbers: 247-10 and 247-30, which likely correspond to different kit sizes or configurations suitable for varying laboratory throughput needs.

• Is the Bilirubin-SL (Direct) Assay sterile or single-use?

  The Bilirubin-SL (Direct) Assay is not described as sterile or single-use in the provided data. As an in vitro diagnostic reagent kit, it is intended for use in clinical laboratory settings where reagents are typically handled under controlled conditions but are not implanted or used in a sterile field; reuse would depend on stability and manufacturer guidelines, which are not specified here.

• What regulatory pathway was used for the Bilirubin-SL (Direct) Assay?

  The Bilirubin-SL (Direct) Assay received FDA 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device. This traditional 510(k) submission was reviewed under product code CIG and regulation number 862.1110 for Diazo Colorimetry, Bilirubin devices in Class II.