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Panels › Clinical Toxicology › Product code DIP · Class 2

Enzyme Immunoassay, Diphenylhydantoin

Regulation 862.3350

0510(k)s in 12 months (44 all time)
0recalls in 12 months (11 all time)
10recalls that name a 510(k)
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Top companies in DIP

Company510(k)sRecalls
Syva Co.100
Abbott Laboratories41
Ortho-Clinical Diagnostics05
E.I. Dupont DE Nemours & Co., Inc.30
Em Diagnostic Systems, Inc.30
Roche Diagnostics Corp.12
Siemens Healthcare Diagnostics, Inc03
Instrumentation Laboratory CO20
Schiapparelli Biosystems, Inc.20
Allied Instrumentation Laboratory10
DateFirm and productCodeLinked 510(k)
Jan 14, 2021Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples to MicroSlide assays and sample and reagent fluid for MicroWell assays. In addition, VersaTips are used to dispense R1 Rea
Terminated		 DIPNone listed
May 9, 2018Ortho-Clinical Diagnostics
VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
Terminated		 DIPK081543
K941142
Jun 12, 2017Ortho-Clinical Diagnostics
VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively meas
Terminated		 DIPK081543
K941142
Oct 29, 2014Siemens Healthcare Diagnostics, Inc.
siemens Dimension Phenytoin Flex Reagent Cartridge The PTN method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydan
Terminated		 DIPK911056
Oct 2, 2014Ortho-Clinical Diagnostics
VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) conc
Terminated		 DIPK941142
Feb 4, 2014Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADV
Terminated		 DIPK011393
Feb 4, 2014Siemens Healthcare Diagnostics, Inc
ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVI
Terminated		 DIPK011393
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog number 8298671 VITROS PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/35
Terminated		 DIPK081543
K941142
Sep 16, 2008Abbott Laboratories Inc.
ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of phenytoin in human serum or plasma.
Terminated		 DIPK993026
Jul 20, 2004Roche Diagnostics Corp.
Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin conjugate and 2- 1 x 38 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 03516989190.
Terminated		 DIPK030428
Jul 20, 2004Roche Diagnostics Corp.
Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin conjugate and 2- 2 x 18 ml anti-phenytoin antibody (mouse monoclonal); latex microparticle. Product 03800458190.
Terminated		 DIPK030428

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