GC BASE W/ 1% GCHI

• K Number: K954986
• Device Name: GC BASE W/ 1% GCHI
• Manufacturer: REMEL, L.P.
• Date Cleared: 1996-02-16 ( 108 days)
• Product Code: JTY
• Regulation Number: 866.2410

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

§ 866.2410 Culture medium for pathogenic

Neisseria spp.(a)
Identification. A culture medium for pathogenicNeisseria spp. is a device that consists primarily of liquid or solid biological materials used to cultivate and identify pathogenicNeisseria spp. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusNeisseria, such as epidemic cerebrospinal meningitis, other meningococcal disease, and gonorrhea, and also provides epidemiological information on these microorganisms.(b)
Classification. Class II (performance standards).

Summary

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