MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM

• K Number: K962843
• Device Name: MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
• Manufacturer: STARPLEX SCIENTIFIC, INC.
• Date Cleared: 1996-09-18 ( 58 days)
• Product Code: JSM
• Regulation Number: 866.2390
• Type: Traditional
• Panel: Microbiology
• Age Range: N/A
• Reference & Predicate Devices: N/A
• Predicate For: K032246

Intended Use

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Device Description

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Summary

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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).