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)
Top companies in DJG
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Drug Test Small (4 substances) Open, Classified |
DJG | None listed |
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Illegally Marketed Open, Classified |
DJG | None listed |
| Jul 2, 2025 | Ortho-Clinical Diagnostics, Inc. VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. Open, Classified |
DJG | K062460 |
| Apr 20, 2020 | Beckman Coulter Inc. Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening Terminated |
DJG | K031002 |
| Apr 20, 2020 | Beckman Coulter Inc. Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators Terminated |
DJG | K984152 |
| Jan 20, 2020 | Carolina Liquid Chemistries Corp Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent Terminated |
DJG | None listed |
| Dec 17, 2019 | Ameditech Inc QuickTox 5 Panel Drug Screen DipCard Terminated |
DJG | K022355 |
| Mar 12, 2018 | Siemens Healthcare Diagnostics, Inc. Syva EMIT II Plus 6-Acetyl morphine
Catalog # for 28 mL: 9R039UL /SMN# 10470440 Terminated |
DJG | K102779 |
| Mar 12, 2018 | Siemens Healthcare Diagnostics, Inc. Syva EMIT II Plus 6-Acetylmorphine
Catalog # for 1000 mL: 9R129UL /SMN# 10481483 Terminated |
DJG | K102779 |
| Mar 21, 2014 | Lin-Zhi International Inc Single Analyte DAU Calibrator (5 mL)
Norbuprenorphine: Cutoff Calibrator;
IVD - for in vitro diagnostic use only;
Lin-Zhi International
Sunnyvale, CA
The Norbuprenorphine Drug of Abuse (DAU) cutoff C Terminated |
DJG | K081008 |
| Aug 23, 2013 | Sarken, Inc. SARKEN STAT! 1- Panel Test Kit-OPI
Product Usage: Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). Terminated |
DJG | None listed |
| May 27, 2011 | Express Diagnostics Int'l., Inc. DrugCheck, Manufactured by: Express Diagnostics Int;l Inc. 1550 Industrial Drive, Blue Earth MN 56013 USA, Model numbers :
70801-4(NxScan OnSite, AMP500-COC-MDMA-MET500-MTD-OP1300-TCH-BUP-pH,SG-NI,CR Terminated |
DJG | K042975 K050186 +2 |
| Jul 28, 2004 | Abbott Health Products, Inc. TDx/TDxFLx Opiates Reagent, Product list number: 9673-60 Terminated |
DJG | K874485 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.