SPECTROLYSE ANTITHROMBIN III (ANTI-XA)

• K Number: K960871
• Device Name: SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
• Manufacturer: MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
• Date Cleared: 1996-08-14 ( 163 days)
• Product Code: JBQ
• Regulation Number: 864.7060
• Type: Traditional
• Panel: Hematology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

AI/ML Overview

Get notified when PDF is available

Summary

Loading...

Regulation Number and Section

§ 864.7060 Antithrombin III assay.

(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).