21 CFR 866.4900 — Support Gels

Immunology (IM) · Part 866 Subpart E—Immunology Laboratory Equipment and Reagents · § 866.4900

Identification

A support gel for clinical use is a device that consists of an agar or agarose preparation that is used while measuring various kinds of, or parts of, protein molecules by various immunochemical techniques, such as immunoelectrophoresis, immunodiffusion, or chromatography.

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
JZRSupport Gels12
Innolitics

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