SAC

Adamts13 Activity Test System

Product code

SAC

Device name

Adamts13 Activity Test System

Device class

Class 2

21 CFR

21 CFR 864.7297

Medical specialty

Hematology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

0 (direct download)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

An ADAMTS13 activity test system is a qualitative or quantitative in vitro diagnostic device intended to detect ADAMTS13 activity in human blood specimens collected from patients being evaluated for thrombotic microangiopathy. This device is indicated to aid in the diagnosis and management of patients being evaluated for thrombotic thrombocytopenic purpura in conjunction with other clinical and laboratory findings.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-02-28.