21 CFR 864.7900 — Test, Thromboplastin Generation
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7900
Identification
A thromboplastin generation test is a device used to detect and identify coagulation factor deficiencies and coagulation inhibitors.
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 |
|---|---|---|---|---|
| GKQ | Test, Thromboplastin Generation | 1 | 1 |
