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K Number
K003767
Device Name
ASSERACHROM HPIA TEST KIT
Manufacturer
DIAGNOSTICA STAGO, INC.
Date Cleared
2001-02-12

(68 days)

Product Code
LCO
Regulation Number
864.7695
Type
Traditional
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 864.7695 Platelet factor 4 radioimmunoassay.

(a)
Identification. A platelet factor 4 radioimmunoassay is a device used to measure the level of platelet factor 4, a protein released during platelet activation by radioimmunoassay. This device measures platelet activiation, which may indicate a coagulation disorder, such as myocardial infarction or coronary artery disease.(b)
Classification. Class II (performance standards).