21 CFR 864.6600 — Osmotic Fragility Testing
Hematology (HE) · Part 864 Subpart G—Manual Hematology Devices · § 864.6600
Identification
An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions.
Classification Rationale
Class I (general controls). This 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 |
|---|---|---|---|---|
| GKE | Osmotic Fragility Testing | 1 | 0 |
