21 CFR 864.8165 — Calibrator For Hemoglobin And Hematocrit Measurement
Hematology (HE) · Part 864 Subpart I—Hematology Reagents · § 864.8165
Identification
A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 2 | 25 |
Special Controls
KRZ — Calibrator For Hemoglobin And Hematocrit Measurement
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
eCFR
