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 Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JTC | Device, Microtiter Diluting/Dispensing | 1 | 66 |