ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000)

• K Number: K962745
• Device Name: ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000)
• Manufacturer: PREPARED MEDIA LABORATORY, INC.
• Date Cleared: 1996-10-02 ( 79 days)
• Product Code: JSN
• Regulation Number: 866.2390

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

§ 866.2390 Transport culture medium.

(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).

Summary

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