21 CFR 864.7140 — Activated Whole Blood Clotting Time

Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7140

Identification

An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
JBPActivated Whole Blood Clotting Time2243rd Party
Innolitics

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