LogoFDA 510(k) Search
K Number
K041155
Device Name
WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
Manufacturer
STANBIO LABORATORY
Date Cleared
2004-10-14

(164 days)

Product Code
DCK,JIT,JIX
Regulation Number
866.5270
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 866.5270 C-reactive protein immunological test system.

(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).