Bilirubin Assay Kit Direct
by Diagnostic Chemicals, Ltd. (Usa) 510(k)
Active
510(k) K843027
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843027 | Date4 Sep 1984 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CIG
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1110
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Bilirubin Assay Kit Direct is a diagnostic in vitro device used for the quantitative measurement of direct (conjugated) bilirubin in serum or plasma. It employs diazo colorimetry, where bilirubin reacts with a diazo reagent to form azobilirubin, which is then spectrophotometrically measured at 600 nm. This method enables precise assessment of conjugated bilirubin levels, aiding in the diagnosis and monitoring of liver function and biliary tract disorders.
This kit is intended for single-use in clinical chemistry laboratories and requires no sterilization beyond standard reagent preparation protocols. It is classified as a Class II device under FDA regulations (21 CFR 862.1110) and was granted 510(k) clearance through the Traditional pathway by the FDA in 1984. The assay is supplied as a reagent kit and must be stored according to manufacturer instructions to maintain stability and accuracy. No MRI safety considerations apply, as it is a non-imaging diagnostic reagent.
Other devices from Diagnostic Chemicals, Ltd. (Usa)
Questions
AI-generated answers, 1 Oct 2026
What is the Bilirubin Assay Kit Direct used for?
The Bilirubin Assay Kit Direct is designed for the quantitative measurement of direct (conjugated) bilirubin in serum or plasma. This helps clinicians diagnose and monitor liver function and biliary tract disorders by assessing conjugated bilirubin levels through a diazo colorimetric reaction, which produces a measurable azobilirubin pigment at 600 nm.
How is the Bilirubin Assay Kit Direct supplied, and is it single-use?
The kit is supplied as a reagent kit, intended for single-use in clinical chemistry laboratories. It does not require sterilization beyond standard reagent preparation protocols, ensuring usability without additional processing.
Does this kit require special storage conditions?
Yes, the Bilirubin Assay Kit Direct must be stored according to the manufacturer’s instructions to maintain stability and accuracy. Proper storage conditions are critical to preserving reagent integrity and ensuring reliable test results.
Is this device approved for use in the U.S.?
Yes, the Bilirubin Assay Kit Direct has received FDA 510(k) clearance through the Traditional pathway, confirming its compliance with U.S. regulatory standards for in vitro diagnostic devices. It is classified as a Class II device under 21 CFR 862.1110.
Are there any safety considerations for this kit, such as MRI compatibility?
No MRI safety considerations apply to this kit, as it is a non-imaging diagnostic reagent. It is designed solely for laboratory use in spectrophotometric analysis and does not involve imaging or electromagnetic interference.