OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT

• K Number: K963139
• Device Name: OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT
• Manufacturer: OLYMPUS AMERICA, INC.
• Date Cleared: 1997-02-06 ( 178 days)
• Product Code: DDD
• Regulation Number: 866.5880

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 866.5880 Transferrin immunological test system.

(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).

Summary

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