NJV · Class II · 21 CFR 862.1215

FDA Product Code NJV: Test, Albumin Cobalt Binding

The Albumin Cobalt Binding Test Is A Quantitative In Vitro Diagnostic Test Used On Human Serum That Detects Ischemia Modified Albumin By Measuring The Cobalt Binding Capacity Of Albumin In Human Serum. Ima Is Intended For Use In Conjunction With Other Tests Such As Ecg And Cardiac Troponin As An Aid To The Short Term Risk Stratification Of Patients Presenting With Chest Pain Suggestive Of Cardiac Origin.

Leading manufacturers include Ischemia Technologies, Inc. and Inverness Medical Innovations, Inc..

2
Total
2
Cleared
59d
Avg days
2003
Since

FDA 510(k) Cleared Test, Albumin Cobalt Binding Devices (Product Code NJV)

2 devices
1–2 of 2
Cleared Dec 16, 2005
ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)
K053196
Inverness Medical Innovations, Inc.
Chemistry · 30d
Cleared Feb 14, 2003
ALBUMIN COBALT BINDING TEST (ACB TEST)
K023824
Ischemia Technologies, Inc.
Chemistry · 88d

About Product Code NJV - Regulatory Context