Home › Device types › DJR
Enzyme Immunoassay, Methadone
FDA product code DJR · Class 2 · Clinical Toxicology
2,825
Registered devices
16
Adverse events
7
Recalls
63
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 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.BluRapids™ — MERCEDES MEDICAL, LLCCEDIA Methadone Assay — Microgenics CorporationDrugSmart Cup 13 — CHEMTRON BIOTECH INCSTATCUP® II — MICRO DISTRIBUTING, L.CHealgen — Healgen Scientific Limited Liability CompanyDrugSmart Cup — CHEMTRON BIOTECH INCAdvin Multi-Drug Screen Test — ADVIN BIOTECH, INC.NOBLE — NOBLE MEDICAL INCINCUP — AMERICAN BIO MEDICA CORPORATIONDrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.Advin Multi-Drug Screen Test — ADVIN BIOTECH, INC.Advin Multi-Drug Screen Test with SVT — ADVIN BIOTECH, INC.DrugCheck — Express Diagnostic Int'l, Inc.QuickTox Drug Screen Dipcard — BRANAN MEDICAL CORPORATIONAdvin Multi-Drug Screen Test — ADVIN BIOTECH, INC.FIRST SIGN® — HEMOSURE INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-11-28 | Alere San Diego Inc. DBA Immunalysis Corporation | The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce values below 100 ng/mL when run on validated clinical chemistry anal |
| 2014-02-05 | Alere San Diego, Inc. | Alere San Diego, Inc. is initiating a recall of the Alere Triage TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation h |
| 2012-05-14 | Alere San Diego, Inc. | A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have significantly decreased precision and accuracy than claime |
| 2010-03-12 | Alere San Diego dba Biosite Innovacon Hemosense Inc | The recall was initiated because Biosite Inc. received an increase in customer calls regarding unexpected positive THC results when using the Triage TOX Drug Sc |
| 2009-05-28 | Alere San Diego, Inc. | Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled. |
| 2008-05-28 | Sun Biomedical Laboratories, Inc. | Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. |
| 2008-05-28 | Sun Biomedical Laboratories, Inc. | Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied. |
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