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Panels › Clinical Toxicology › Product code LEH · Class 2

Radioimmunoassay, Vancomycin

Regulation 862.3950

0510(k)s in 12 months (31 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
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Top companies in LEH

Company510(k)sRecalls
Abbott Laboratories40
Beckman Coulter, Inc.12
Ortho-Clinical Diagnostics, Inc.12
Roche Diagnostics Operations, Inc.03
Siemens Healthcare Diagnostics, Inc.21
Biokit, S.A.20
Innotron of Oregon, Inc.20
Roche Diagnostic Systems, Inc.20
Roche Diagnostics Corp.11
Seradyn, Inc.11
DateFirm and productCodeLinked 510(k)
May 27, 2025Mckesson Medical-Surgical Inc. Corporate Office
ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT.
Open, Classified		 LEHK043386
Jul 23, 2019Roche Diagnostics Operations, Inc.
Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
Terminated		 LEHK152245
Jul 23, 2019Roche Diagnostics Operations, Inc.
Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
Terminated		 LEHK152245
Feb 21, 2017Ortho-Clinical Diagnostics
VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5
Terminated		 LEHK043386
Aug 1, 2016Roche Diagnostics Operations, Inc.
ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ONLINE TDM Vancomycin assay is for the quantitative determination
Terminated		 LEHK060586
Aug 9, 2012Siemens Healthcare Diagnostics, Inc.
Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitative measurement of vancomycin in human serum and plasma on the Dimension Vista system.
Terminated		 LEHK061655
Apr 29, 2008Seradyn, Inc.
Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.
Terminated		 LEHK050419
Jun 9, 2007Roche Diagnostics Corp.
Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.
Terminated		 LEHK060586
May 18, 2006Beckman Coulter Inc
SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.
Terminated		 LEHK013076
Nov 18, 2005Ortho-Clinical Diagnostics
VITROS VANC (vancoymycin) Reagent, REF #680 1709. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626
Terminated		 LEHK043386
Jul 23, 2004Beckman Coulter Inc
Synchron Liquid Comprehensive Chemistry Control Serum. Part numbers: 660710, 657365.
Terminated		 LEHK013235
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
Package Insert for TDx/TDxFLx and TDxFLx Phenobarbital II Reagents, REF 9500, item number 69-5162/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Terminated		 LEHK900940

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