Home › Device types › DJG
Enzyme Immunoassay, Opiates
FDA product code DJG · Class 2 · Clinical Toxicology
0
Registered devices
25
Adverse events
13
Recalls
215
510(k) clearances
Devices with this code
Syva® RapidTest d.a.u.® 10 — Siemens Healthcare Diagnostics Inc.Healgen — Healgen Scientific Limited Liability CompanyT-Cup — WONDFO USA CO., LTD.NOBLE — NOBLE MEDICAL INCARK™ Fentanyl II Assay — ARK DIAGNOSTICS INCPreview — WONDFO USA CO., LTD.INSTA-SCREEN-2TM Cup — NOBLE MEDICAL INCAdvin Multi-Drug Screen Test — ADVIN BIOTECH, INC.reditest® — REDWOOD TOXICOLOGY LABORATORY, INC.QuickProfile™ Drugs of Abuse Panel 7 Test — LUMIQUICK DIAGNOSTICS, INC.Alere iScreen Dx — Instant Technologies, Inc.Syva® Emit® II Plus Buprenorphine Assay — Siemens Healthcare Diagnostics Inc.BluRapids™ — MERCEDES MEDICAL, LLCDrugSmart Cup 13 — CHEMTRON BIOTECH INCSTATCUP® II — MICRO DISTRIBUTING, L.CHealgen — Healgen Scientific Limited Liability CompanyDrugSmart Cup — CHEMTRON BIOTECH INCFastect II Drug Screen Dipstick Test — BRANAN MEDICAL CORPORATIONHigh Sensitivity — Alere San Diego, Inc.Advin Multi-Drug Screen Test — ADVIN BIOTECH, INC.NOBLE — NOBLE MEDICAL INCQuickTox Drug Screen Dipcard — AMEDITECH INC.INCUP — AMERICAN BIO MEDICA CORPORATIONDrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-06-12 | Ortho-Clinical Diagnostics, Inc. | Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable t |
| 2020-01-20 | Carolina Liquid Chemistries Corp | Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified customers th |
| 2019-09-04 | Beckman Coulter Inc. | Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of certain compounds in urine may result |
| 2019-09-04 | Beckman Coulter Inc. | Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may res |
| 2019-02-15 | Ameditech Inc | Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere iScreen Drugs of Abuse Dip Test (P/N X11-IS10-22015-DX LOT #18 |
| 2018-03-12 | Siemens Healthcare Diagnostics, Inc. | Incorrect calibrator level listed in qualitative calibration steps |
| 2018-03-12 | Siemens Healthcare Diagnostics, Inc. | Incorrect calibrator level listed in qualitative calibration steps |
| 2014-02-18 | Lin-Zhi International Inc | Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified through quality control testing. The cutoff calibrator was recoveri |
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