Raichem Bilirubin Standard
by Reagents Applications, Inc. 510(k)
Active
510(k) K882726
Overview
The Raichem Bilirubin Standard is a primary calibrator for clinical chemistry assays, designed to measure bilirubin levels in patient samples. It serves as a reference material to ensure the accuracy and precision of diagnostic tests for jaundice and liver function evaluation.
This device is supplied as a liquid reagent for in vitro use in clinical laboratories. It is classified as a Class 2 medical device under product code JIS and has received FDA 510(k) clearance through the Traditional pathway. The standard is intended for single-use and must be stored according to manufacturer instructions to maintain stability and reliability.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK882726 | Date29 Aug 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Raichem(Tm) Bilirubin Standard
- 510(k) Number
- FDA Product Code
- JIS
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1150
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent