21 CFR 864.6150 — Tube, Collection, Capillary Blood
Hematology (HE) · Part 864 Subpart G—Manual Hematology Devices · § 864.6150
Identification
A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capillary action.
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 § 864.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GIO | Tube, Collection, Capillary Blood | 1 | 22 |
