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K Number
K961024
Device Name
BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB
Manufacturer
PRINCETON BIOMEDITECH CORP.
Date Cleared
1997-02-04

(327 days)

Product Code
KTN
Regulation Number
866.5640
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 866.5640 Infectious mononucleosis immunological test system.

(a)
Identification. An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.(b)
Classification. Class II (performance standards).