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Panels › Clinical Toxicology › Product code DJG · Class 2

Enzyme Immunoassay, Opiates

Regulation 862.3650

3510(k)s in 12 months (215 all time)
2recalls in 12 months (13 all time)
9recalls that name a 510(k)
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Top companies in DJG

Company510(k)sRecalls
Lin-Zhi International, Inc.161
Microgenics Corp.130
Immunalysis Corporation110
Guangzhou Wondfo Biotech Co., Ltd.80
Syva Co.80
Medtox Diagnostics, Inc.70
ACON Laboratories, Inc.60
Diagnostic Products Corp.60
Phamatech60
Siemens Healthcare Diagnostics, Inc.42
Decided510(k)Device and applicantCode
Apr 17, 2015K143599Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000
Chemtron Biotech, Inc.
DJG
Mar 9, 2015K150275Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acet
Immunalysis Corporation
DJG
Feb 25, 2015K150179CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
Guangzhou Wondfo Biotech Co., Ltd., CN
DJG
Feb 13, 2015K141205LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6
Lin-Zhi International, Inc.
DJG
Feb 12, 2015K141803IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY
Immunalysis Corporation
DJG
Jan 27, 2015K143187Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card)
Healgen Scientific,, LLC
DJG
Jan 8, 2015K140671OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE
Omega Laboratories, Inc.
DJG
Oct 16, 2014K142280Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card)
Healgen Scientific,, LLC
DJG
Oct 9, 2014K142396Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette Tests
Chemtron Biotech, Inc.
DJG
Aug 20, 2014K140748ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD
Co-Innovation Biotech Co., Ltd., CN
DJG
Jul 1, 2014K141406IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS
Immunalysis Corporation
DJG
Jun 13, 2014K141055LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML)
Lin-Zhi International, Inc.
DJG
Apr 8, 2014K140089CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)
Guangzhou Wondfo Biotech Co., Ltd.
DJG
Feb 26, 2014K130650STATUS DS OXY
Princeton BioMeditech Corp.
DJG
Jan 24, 2014K133642RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK
Biophor Diagnostics, Inc.
DJG
Jan 17, 2014K131168IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY
Immunalysis Corporation
DJG
Sep 26, 2013K130275QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
Tianjin New Bay Bioresearch Co., Ltd.
DJG
May 7, 2013K122064FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE
Tianjin New Bay Bioresearch Co., Ltd.
DJG
Apr 9, 2013K130665WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
Guangzhou Wondfo Biotech Co., Ltd.
DJG
Feb 14, 2013K130055ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
Guangzhou Wondfo Biotech Co., Ltd.
DJG
Feb 8, 2013K123799PSYCHEMEDICS MICROPLATE EIA FOR OXYCODONE IN HAIR
Psychemedics Corp.
DJG
Aug 24, 2012K113747RANDOX OPIATES ASSAY
Randox Laboratories Limited, GB
DJG
Jun 1, 2012K120763LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS
Lin-Zhi International, Inc.
DJG
May 8, 2012K120761LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS
Lin-Zhi International, Inc.
DJG
May 1, 2012K111926PSYCHEMEDICS OPIATES EIA
Psychemedics Corp.
DJG
Mar 12, 2012K113624WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
Guangzhou Wondfo Biotech Co., Ltd.
DJG
Dec 13, 2011K103161OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES
Omega Laboratories, Inc.
DJG
Sep 8, 2011K112310WONDFO METHADONE URINE TEST,OPIATE TEST
Guangzhou Wondfo Biotech Co., Ltd.
DJG
Jul 15, 2011K110298OPIATE ENZYME IMMUNOASSAY
Lin-Zhi International, Inc.
DJG
Apr 8, 2011K101754THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
Microgenics Corp.
DJG
Mar 18, 2011K102779EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C
Siemens Healthcare Diagnostics, Inc.
DJG
Feb 11, 2011K093867ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A
Roche Diagnostics
DJG
Oct 18, 2010K100951MEDTOX BUPRENORPHINE TEST
Medtox Diagnostics, Inc.
DJG
Aug 25, 2010K093175WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES
Guangzhou Wondfo Biotech Co., Ltd.
DJG
Jul 6, 2010K1011956-ACETYLMORPHINE ENZYME IMMUNOASSAY WITH 6-ACETYLMORPHINE CALIBRATORS AND CONTROLS
Lin-Zhi International, Inc.
DJG
Jul 6, 2010K100051INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI-DRUG OF ABUSE URINE TEST (PANEL, CUP)
Alfa Scientific Designs, Inc.
DJG
Apr 5, 2010K100023PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM
Medtox Diagnostics, Inc.
DJG
Feb 24, 2010K091612UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST;
Ucp Biosciences, Inc.
DJG
Jul 30, 2009K090844BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS
Lin-Zhi International, Inc.
DJG
Jul 24, 2009K091454PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM
Medtox Diagnostics, Inc.
DJG
Dec 22, 2008K081008BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
Lin-Zhi International, Inc.
DJG
Nov 21, 2008K082508FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD
Branan Medical Corporation
DJG
Jun 1, 2007K063699IMDX SYSTEMS
Novx Systems, Inc.
DJG
May 7, 2007K063545MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, DIP-STRIP), COCAINE, METHAMPHETAMINE
Alfa Scientific Designs, Inc.
DJG
Dec 20, 2006K063015AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150
Ameditech, Inc.
DJG
Dec 15, 2006K062460VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III
Ortho-Clinical Diagnostics, Inc.
DJG
Aug 7, 2006K060760RAPIDONE-BUPRENORPHINE TEST
American Bio Medica Corp.
DJG
Jul 25, 2006K060527INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT-CONFIRMATORY BUP/NBUP URINE TEST
Alfa Scientific Designs, Inc.
DJG
Jul 21, 2006K051958MP RAPIDOXY TEST STRIP, MODEL 07RD-7073
Mp Biomedicals, LLC
DJG
Jun 15, 2006K053037ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100
Acro Biotech, LLC
DJG

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