JPF · Prothrombin-Proconvertin And Thrombotest
Hematology · 21 CFR 864.7735 · Class 2
Overview
| Product Code | JPF |
|---|---|
| Device Name | Prothrombin-Proconvertin And Thrombotest |
| Regulation | 21 CFR 864.7735 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
The prothrombin-proconvertin test and thrombotest are devices used in the regulation of coumarin therapy (administration of a coumarin anticoagulant such as sodium warfarin in the treatment of venous thrombosis and pulmonary embolism) and as a diagnostic test in conjunction with, or in place of, the Quick prothrombin time test to detect coagulation disorders.
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.
Special Controls
*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.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
