21 CFR 864.7875 — Test, Thrombin Time
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7875
Identification
A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GJA | Test, Thrombin Time | 2 | 20 | 3rd Party |
| GJB | Thrombin | 2 | 1 | 3rd Party |
