OYGClass II

St2 Assay

Clinical Chemistry · 21 CFR 862.1117

Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.

MDR events0All time

Recalls1All time

Registered firms1Currently listed

510(k) clearances1All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

1 recall events for this product code

Critical Diagnostics
TerminatedJul 13, 2012
Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E.
The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate test results for specimens when using the Presage ST2 Assay kits.
Z-2012-2012 · View FDA record ↗

Registered firms

1 firms currently registered for this product code

Drg Instruments Gmbh
MARBURG Hesse, DE

510(k) clearances

1 clearances for this product code

Critical Care Diagnostics, Inc. (Dba Critical DiagDec 9, 2011
K111452 · PRESAGE ST2 ASSAY