Adamts13 Activity Test System

SAC · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.7297

Classification

FDA Product Code: SAC
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.7297
Review panel: HE
Medical specialty: Hematology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown