21 CFR 864.7750 — Test, Time, Prothrombin
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7750
Identification
A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GJS | Test, Time, Prothrombin | 2 | 127 | |
| ODV | Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System | 2 | 1 | 3rd Party |
