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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
Jan 29, 2026K252684Labcorp Fentanyl Urine Visual Test
Medtox Diagnostics, Inc.
DJG
Jan 23, 2026K250741Evidence MultiSTAT DOA Urine MultiPlex
Randox Laboratories Limited, GB
DJG
Jan 16, 2026K253082LZI Buprenorphine II Enzyme Immunoassay
Lin-Zhi International, Inc.
DJG
Sep 11, 2025K252520SEFRIA™ Hydrocodone Oral Fluid
Immunalysis Corporation
DJG
Aug 15, 2025K251972Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen® Immunofluorescence Analyzer (
Healgen Scientific,, LLC
DJG
Jun 18, 2025K251634LZI Fentanyl III Enzyme Immunoassay
Lin-Zhi International, Inc.
DJG
Jun 14, 2024K240124BioSieve™ Fentanyl FIA Test Kit; BioSieve™ ToxiSmart FIA Reader
Vivachek Biotech (Hangzhou) Co., Ltd., CN
DJG
May 10, 2024K240698Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard
Guangzhou Decheng Biotechnology Co., Ltd., CN
DJG
Mar 8, 2024K231904Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
Co-Innovation Biotech Co., Ltd., CN
DJG
Feb 23, 2024K232228Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug U
Shanghai Accurature Diagnostics Co., Ltd., CN
DJG
Jan 9, 2024K232597LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipc
Hangzhou Laihe Biotech Co., Ltd., CN
DJG
Dec 20, 2023K232736Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi
Chemtron Biotech, Inc.
DJG
Dec 13, 2023K232659Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
Guangzhou Decheng Biotechnology Co., Ltd., CN
DJG
Nov 9, 2023K231752ARK Hydrocodone Assay
Ark Diagnostics, Inc.
DJG
Oct 5, 2023K221550Evidence MultiSTAT DOA Urine MultiPlex
Randox Laboratories Limited, GB
DJG
Oct 5, 2023K220451Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
Randox Laboratories Limited, GB
DJG
Sep 27, 2023K231007CEDIA Heroin Metabolite (6-AM) Assay
Microgenics Corporation
DJG
Jul 31, 2023K231698AllTest Fentanyl Rapid Test (Urine)
Hangzhou AllTest Biotech Co., Ltd., CN
DJG
Jul 25, 2023K221605Emit® II Plus Buprenorphine Assay
Siemens Healthcare Diagnostics, Inc.
DJG
Mar 31, 2023K230238BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx
Shenzhen Bioeasy Biotechnology Co., Ltd., CN
DJG
Feb 6, 2023K222955Xenta Drug Screen Cup, Xenta Drug Screen Dipcard
Xenta Biomedical Science Co., Ltd., CN
DJG
Dec 13, 2022K220046Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11
Shenzhen Superbio Technology Co., Ltd., CN
DJG
May 9, 2022K203527Immunalysis Tapentadol Urine HEIA
Lmmunalysis Corporation
DJG
Dec 22, 2021K203564SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
Immunalysis Corporation
DJG
Aug 12, 2021K201630AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests
Assure Tech. (Hangzhou) Co, Ltd., CN
DJG
Jul 27, 2021K201326Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEI
Psychemedics Corporation
DJG
Sep 17, 2020K202007LZI Oxycodone III Enzyme Immunoassay
Lin-Zhi International, Inc.
DJG
Sep 17, 2020K201494ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
Advin Biotech, Inc.
DJG
Aug 7, 2020K201938LZI Fentanyl II Enzyme Immunoassay
Lin-Zhi International, Inc.
DJG
Jun 4, 2020K201223LZI Tramadol Enzyme Immunoassay
Lin-Zhi International, Inc.
DJG
Feb 26, 2020K200197ARK Fentanyl II Assay
Ark Diagnostics, Inc.
DJG
Dec 16, 2019K192943CEDIA Heroin Metabolite (6-AM) assay
Microgenics Corporation
DJG
Apr 18, 2019K182103Psychemedics Microplate EIA for Fentanyl in Hair
Psychemedics Corporation
DJG
Mar 29, 2019K182123ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card
Advin Biotech, Inc.
DJG
Dec 10, 2018K182280ARK Tramadol Assay
Ark Diagnostics, Inc.
DJG
Dec 3, 2018K181159LZI Fentanyl Enzyme Immunoassay
Lin-Zhi International, Inc.
DJG
Jun 6, 2018K180427ARK Fentanyl Assay
Ark Diagnostics, Inc.
DJG
Apr 19, 2018K172416Synermed Opiate Enzyme Immunoassay
Infrared Laboratory Systems, LLC (Dba Synermed)
DJG
Feb 13, 2018K173195DRI Hydrocodone Assay
Microgenics Corporation
DJG
Nov 22, 2017K173183CEDIA Heroin Metabolite (6-AM) Assay
Microgenics Corporation
DJG
Oct 18, 2017K172910Emit II Plus Oxycodone Assay
Siemens Healthcare Diagnostics, Inc.
DJG
Jun 14, 2017K161216Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators
Immunalysis Corporation
DJG
Apr 6, 2017K163101CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II C
Microgenics Corporation
DJG
Apr 26, 2016K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
Co-Innovation Biotech Co., Ltd., CN
DJG
Apr 18, 2016K153192Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests
Chemtron Biotech, Inc.
DJG
Nov 9, 2015K152551First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Dru
W.H.P.M., Inc.
DJG
Oct 23, 2015K150606Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit
Siemens Healthcare Diagnostics, Inc.
DJG
Oct 9, 2015K150502DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls
Microgenics Corporation
DJG
Jul 1, 2015K151478Wondfo CR3 Keyless Split Sample Cup
Guangzhou Wondfo Biotech Co., Ltd., CN
DJG
May 20, 2015K143502Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calib
Immunalysis Corporation
DJG

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