LDMClass I

Instrumentation, High Pressure Liquid Chromatography

Clinical Chemistry · 21 CFR 862.2260

MDR events7All time

Recalls1All time

Registered firms12Currently listed

510(k) clearances19All time

Recent MDR events

7 adverse event reports on file

Event type breakdown

Malfunction6

Injury1

Most-reported manufacturers

Ortho-clinical Diagnostics4 Waters Corporation3

Recalls

1 recall events for this product code

Abbott Health Products, Inc.
TerminatedJan 10, 2004
AxSYM Tricyclic Antidepressants Reagent, Distributed under the following label: AxSYM Tricyclic Antidepressants Reagents, Abbott Laboratories USA, North Chicago
Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay.
Z-0323-04 · View FDA record ↗

Registered firms

12 firms currently registered for this product code

510(k) clearances

19 clearances for this product code