CDLClass II

Berthelot Indophenol, Urea Nitrogen

Clinical Chemistry · 21 CFR 862.1770

MDR events1All time

Recalls1All time

Registered firms2Currently listed

510(k) clearances16All time

Recent MDR events

1 adverse event reports on file

SYNCHON CX DELTA CLINICAL SYSTEMNov 15, 2011
MalfunctionBeckman Coulter, Inc.2050012-2011-06975

Event type breakdown

Malfunction1

Most-reported manufacturers

Beckman Coulter, Inc.1

Recalls

1 recall events for this product code

Sterling Diagnostics, Inc.
TerminatedDec 29, 2016
Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys
Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.
Z-0936-2017 · View FDA record ↗

Registered firms

2 firms currently registered for this product code

510(k) clearances

16 clearances for this product code