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Panels › Clinical Toxicology › Product code LFM · Class 2

Enzyme Immunoassay, Digitoxin

Regulation 862.3300

0510(k)s in 12 months (20 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
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Top companies in LFM

Company510(k)sRecalls
Diagnostic Products Corp.40
Abbott Laboratories30
Dade Behring, Inc.20
Ortho-Clinical Diagnostics02
QUIDEL ORTHO02
American Dade10
Bayer Corp.10
Chiron Diagnostics Corp.10
E.I. Dupont DE Nemours & Co., Inc.10
Eastman Kodak Company10
DateFirm and productCodeLinked 510(k)
Jan 10, 2025QUIDEL ORTHO
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a
Open, Classified		 LFMK942610
Jan 10, 2025QUIDEL ORTHO
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a
Open, Classified		 LFMK942610
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products DGXN Slides packaged as 90 slides/pack catalog number 8343386 VITROS DGXN Slides quantitatively measure digoxin (DGXN) concentration in serum using VITROS 250/350/950/5,1 FS
Terminated		 LFMK942610
Dec 11, 2012Siemens Healthcare Diagnostics, Inc
Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic use in the quantitative determination of digitoxin in s
Terminated		 LFMK970546
Aug 15, 2012Ortho-Clinical Diagnostics
VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. Product Usage: Inten
Terminated		 LFMK942610

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