Laser CRP Kit (C-Reactive Protein Reagents)
by Behring Diagnostics, Inc. 510(k)
Active
510(k) K855057
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK855057 | Date26 Feb 1986 | 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- Withdrawn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
- DCN
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5270
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
This device is a system test for C-reactive protein (CRP) reagents, as defined by its device name and classification. It is a diagnostic reagent kit used for the detection of C-reactive protein in serum samples.
It is supplied as a kit for use in diagnostic laboratories and has received FDA 510(k) clearance (K855057) under product code DCN, regulation number 866.5270, and is classified as a Class II device in the immunology specialty. The device is intended for in vitro diagnostic use and is not described as sterile, single-use, reusable, or MRI-safe in the provided data.
Other devices from Behring Diagnostics, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the LASER CRP KIT used for?
The LASER CRP KIT is a diagnostic reagent kit used for the detection of C-reactive protein in serum samples, intended for in vitro diagnostic use in laboratories to measure CRP levels as part of clinical testing.
How is the LASER CRP KIT supplied and what is its format?
The LASER CRP KIT is supplied as a kit containing reagents for diagnostic laboratory use, designed for in vitro testing of serum samples to detect C-reactive protein, though specific component details or format are not provided in the device data.
Is the LASER CRP KIT sterile, single-use, or reusable?
The device data does not describe the LASER CRP KIT as sterile, single-use, or reusable; it is intended for in vitro diagnostic use, but no specifications regarding sterility or reuse are provided in the authorization details.