510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NRIClass II

Autoantibodies, Nuclear Pore Glycoprotein Gp210

21 CFR 866.5090 / Immunology
FDA source (opens on fda.gov)

NRI is the FDA product code for Autoantibodies, Nuclear Pore Glycoprotein Gp210, a class II device type, regulated under 21 CFR 866.5090. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NRI
Device name
Autoantibodies, Nuclear Pore Glycoprotein Gp210
FDA 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.
Regulation
21 CFR 866.5090
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code NRI

By decision year
2 clearances under product code NRI with a decision year between 2004 and 2006, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NRI by decision year
YearClearances
20041
20061

Applicants with the most clearances

Product code NRI
Applicants holding the most 510(k) clearances under product code NRI
ApplicantClearances
Inova Diagnostics, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code