NYOClass II
Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody
Immunology · 21 CFR 866.5100
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.
MDR events5All time
Recalls0All time
Registered firms7Currently listed
510(k) clearances4All time
Recent MDR events
5 adverse event reports on file
- HER2 CISH PHARMDX KITJan 16, 2014MalfunctionDako Denmark A/s9610099-2014-00008
- HER2 CISH PHARMDX KITJan 16, 2014MalfunctionDako Denmark A/s9610099-2014-00004
- VISTANov 20, 2012MalfunctionTerumo Bct1722028-2012-00879
- VISTAJul 26, 2012MalfunctionTerumo Bct1722028-2012-00526
- VISTA INFORMATION SYSTEMJun 24, 2012MalfunctionTerumo Bct1722028-2012-00381
Event type breakdown
Malfunction5
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
7 firms currently registered for this product code
510(k) clearances
4 clearances for this product code
- Phadia ABSep 13, 2021
K202541 · EliA RNA Pol III
- Immco Diagnostics, Inc.Mar 30, 2018
K172078 · ImmuLisa Enhanced RNA POL III Antibody ELISA
- Inova Diagnostics, Inc.Apr 11, 2007
K070066 · QUANTA LITE RNA POL III ELISA
- Mbl International CorporationJun 19, 2006
K060431 · ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805