NYO · Class II · 21 CFR 866.5100

FDA Product Code NYO: Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody

The Anti-rna Polymerase Iii Test Is A Semi-quantitative Elisa For The Detection Of Anti-rna Polymerase Iii Antibodies In Human Serum. The Test Result Is Used As An Aid In The Diagnosis Of Systemic Sclerosis (ssc) In Conjunction With The Clinical And Other Laboratory Findings. For In-vitro Diagnostic Use.

Leading manufacturers include Immco Diagnostics, Inc. and Phadia AB.

4
Total
4
Cleared
213d
Avg days
2006
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody Devices (Product Code NYO)

4 devices
1–4 of 4
Cleared Sep 13, 2021
EliA RNA Pol III
K202541
Phadia AB
Immunology · 376d
Cleared Mar 30, 2018
ImmuLisa Enhanced RNA POL III Antibody ELISA
K172078
Immco Diagnostics, Inc.
Immunology · 263d

About Product Code NYO - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code NYO since 2006, with 4 receiving FDA clearance (average review time: 213 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.