21 CFR 864.7735 — Prothrombin-Proconvertin And Thrombotest
Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7735
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JPF | Prothrombin-Proconvertin And Thrombotest | 2 | 0 |
Special Controls
JPF — Prothrombin-Proconvertin And Thrombotest
*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.
eCFR
