Bilirubin-SL (Total) Assay

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K974874 ↗

FDA Product Code

CIG

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Calcium, Catalogue Number 122-20

  Class II

  FDA 510(k) K881054 Active Cleared 18 Apr 1988

• Vma Assay Kit

  Class I

  FDA 510(k) K843379 Active Cleared 28 Sep 1984

• Aspartate Aminotransferase Assay Kit (Ifcc)

  Class II

  FDA 510(k) K880692 Active Cleared 27 May 1988

• Acid Phosphatase (Kinetic) Cat. # 320-06

  Class II

  FDA 510(k) K875209 Active Cleared 1 Feb 1988

• Serum Iron & Serum Iron Binding Capacity

  Class I

  FDA 510(k) K842156 Active Cleared 7 Aug 1984

• Chloride Cat. # 152-17

  Class II

  FDA 510(k) K875208 Active Cleared 18 Apr 1988

See all devices from Diagnostic Chemicals, Ltd. (Usa) →

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

  The Bilirubin-SL (Total) Assay Kit is designed for the quantitative measurement of total bilirubin levels in serum samples. Bilirubin is a byproduct of red blood cell breakdown, and its levels are clinically important for diagnosing and monitoring conditions like jaundice, liver disease, and hemolytic anemia. The assay uses diazo colorimetry—a chemical reaction between bilirubin and 2,4-dichlorophenyl diazonium salt—to produce a colored compound, enabling accurate quantification in clinical chemistry laboratories.

• How is the Bilirubin-SL (Total) Assay Kit supplied, and what are its handling requirements?

  The Bilirubin-SL (Total) Assay Kit is supplied as a reagent kit intended for single-use only. It must be handled according to standard clinical laboratory protocols, including proper storage conditions to maintain reagent integrity. Since it is not sterile (no sterility claims are made), it should be used in a controlled laboratory environment where contamination risks are minimized. Always follow the manufacturer’s instructions for preparation, mixing, and disposal to ensure accurate and safe results.

• Is the Bilirubin-SL (Total) Assay Kit reusable, or is it intended for single-use?

  The Bilirubin-SL (Total) Assay Kit is explicitly intended for single-use. Reusing reagents can compromise accuracy, introduce contamination, or alter the chemical reaction required for reliable bilirubin measurement. Clinical laboratories should adhere to this guideline to ensure consistent and valid test results while minimizing waste and cross-contamination risks.

• What storage conditions are recommended for the Bilirubin-SL (Total) Assay Kit?

  While specific storage conditions are not detailed in the regulatory data, reagent kits like this typically require protection from extreme temperatures, light exposure, and moisture. The kit should be stored in a clean, dry environment at room temperature (unless otherwise specified by the manufacturer) to preserve reagent stability. Always check the packaging for any additional storage instructions and avoid freezing, as this can degrade the reagents and affect assay performance.

• What regulatory pathway was used for the FDA clearance of the Bilirubin-SL (Total) Assay Kit?

  The Bilirubin-SL (Total) Assay Kit received FDA clearance through the Traditional 510(k) pathway, which demonstrates that it is substantially equivalent to a legally marketed device already on the market. This classification (Class 2) and product code (CIG) indicate it is intended for use in clinical chemistry laboratories for diagnostic purposes. The clearance was granted under FDA regulation 862.1110, and the device was reviewed by the Clinical Chemistry (CH) Advisory Committee.