21 CFR 866.2500 — Device, Microtiter Diluting/Dispensing

Microbiology (MI) · Part 866 Subpart C—Microbiology Devices · § 866.2500

Identification

A microtiter diluting and dispensing device is a mechanical device intended for medical purposes to dispense or serially dilute very small quantities of biological or chemical reagents for use in various diagnostic procedures.

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
JTCDevice, Microtiter Diluting/Dispensing166
Innolitics

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