21 CFR 866.2580 — Device, Gas Generating

Microbiology (MI) · Part 866 Subpart C—Microbiology Devices · § 866.2580

Identification

A gas-generating device is a device intended for medical purposes that produces predetermined amounts of selected gases to be used in a closed chamber in order to establish suitable atmospheric conditions for cultivation of microorganisms with special atmospheric requirements. The device aids in the diagnosis of disease.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KZJDevice, Gas Generating118
Innolitics

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