NRI · Class II · 21 CFR 866.5090

FDA Product Code NRI: Autoantibodies, Nuclear Pore Glycoprotein Gp210

The Device Is Used For The Detection, In Human Serum Or Plasma, Of Autoantibodies To Gp210 (nuclear Pore Glycoprotein Gp210) As An Aid In The Diagnosis Of Primary Biliary Cirrhosis.

Leading manufacturers include Inova Diagnostics, Inc..

2
Total
2
Cleared
96d
Avg days
2004
Since

FDA 510(k) Cleared Autoantibodies, Nuclear Pore Glycoprotein Gp210 Devices (Product Code NRI)

2 devices
1–2 of 2
Cleared Oct 18, 2006
QUANTA LITE PBC SCREEN IGG/IGA ELISA
K061842
Inova Diagnostics, Inc.
Immunology · 111d
Cleared Jun 25, 2004
QUANTA LITE GP210 ELISA
K040885
Inova Diagnostics, Inc.
Immunology · 81d

About Product Code NRI - Regulatory Context