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Panels › Clinical Toxicology › Product code DJR · Class 2

Enzyme Immunoassay, Methadone

Regulation 862.3620

0510(k)s in 12 months (63 all time)

0recalls in 12 months (9 all time)

7recalls that name a 510(k)

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Top companies in DJR

Company	510(k)s	Recalls
Syva Co.	6	0
Lin-Zhi International, Inc.	5	0
Sun Biomedical Laboratories, Inc.	2	2
Abbott Laboratories	3	0
Alere San Diego, Inc.	0	3
Diagnostic Reagents, Inc.	3	0
Randox Laboratories, Ltd.	3	0
W.H.P.M., Inc.	3	0
Abbott Laboratories HPD/ADD/GPRD	0	2
Alfa Scientific Designs, Inc.	2	0

Date	Firm and product	Code	Linked 510(k)
Nov 28, 2017	Alere San Diego Inc. DBA Immunalysis Corporation lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cut Terminated	DJR	K151395
Mar 17, 2014	Alere San Diego, Inc. Product Brand Name(s): Alere Triage TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a labeled kit box. Indications for use: The Alere Triage T Terminated	DJR	K060791
Oct 10, 2012	Alere San Diego, Inc. Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative dete Terminated	DJR	K060791
Jul 19, 2012	Alere San Diego, Inc. Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of t Terminated	DJR	K060791
Apr 20, 2012	Alere San Diego dba Biosite Innovacon Hemosense Inc Triage TOX Drug Screen (MTD) Panel, Model # 94400. Type of Packaging: 25 individually pouched devices in a labeled kit box. The Triage TOX Drug Screen is a fluorescence immunoassay intended to be use Terminated	DJR	K060791
Sep 17, 2008	Sun Biomedical Laboratories, Inc. VisuaLine Tricyclic Antidepressants: Six Dip (COC-THC-OPI-MET-BZD-OXD); Six Dip (COC-THC-OPI-MET-PCP-OXD); Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD); Nine Dip (COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA); Terminated	DJR	None listed
Sep 17, 2008	Sun Biomedical Laboratories, Inc. VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test completed by visual color comparison used for the detection of drugs of abuse. Terminated	DJR	None listed
Feb 4, 2004	Abbott Laboratories HPD/ADD/GPRD ADx Methadone, list 9676-55; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated	DJR	K884968
Feb 4, 2004	Abbott Laboratories HPD/ADD/GPRD TDx/TDxFLx Methadone, list 9676-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated	DJR	K884968

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