DeviceClearance

Product code NRI— Immunology

QUANTA LITE GP210 ELISA

Classification name
Autoantibodies, Nuclear Pore Glycoprotein Gp210
Device class
Class 2
Regulation
21 CFR 866.5090
Advisory panel
Immunology
Total cleared
2
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code NRI under 21 CFR 866.5090, via openFDA

Market context for product code NRI

FDA has cleared 2 devices under product code NRI between 2004 and 2006, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NRI

Recent clearances under product code NRI

Data sourced from openFDA. This site is unofficial and independent of the FDA.