Bilirubin Standard-Lyophilized
by Dow Instruments & Reagents, Inc. 510(k)
Active
510(k) K830469
Overview
Bilirubin Standard-Lyophilized is a secondary calibrator used in clinical chemistry for the measurement of bilirubin levels. It is a diagnostic tool designed to ensure accuracy and consistency in laboratory testing procedures.
The device is supplied in a lyophilized (freeze-dried) form for stability and is intended for use in clinical laboratory settings. It has received FDA 510(k) clearance under regulation number 862.1150, with product code JIT, and is classified as a Class II medical device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830469 | Date24 Mar 1983 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- JIT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1150
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dow Instruments & Reagents, Inc.
Questions
What is the Bilirubin Standard-Lyophilized used for?
The Bilirubin Standard-Lyophilized is a secondary calibrator used in clinical chemistry laboratories to ensure accuracy and consistency in the measurement of bilirubin levels during diagnostic testing procedures.
How is the Bilirubin Standard-Lyophilized supplied?
The device is supplied in a lyophilized (freeze-dried) form, which enhances stability and extends shelf life. This form requires reconstitution before use in laboratory testing procedures.
What is the regulatory classification of this device?
The Bilirubin Standard-Lyophilized has received FDA 510(k) clearance under regulation number 862.1150, with product code JIT, and is classified as a Class II medical device for clinical chemistry applications.
Is this device single-use or reusable?
The device is supplied as a lyophilized standard that is typically reconstituted for use in calibrating laboratory equipment. The specific usage instructions would depend on the laboratory's protocol and the manufacturer's guidelines.