Home › Device types › DJR
Enzyme Immunoassay, Methadone
FDA product code DJR · Class 2 · Clinical Toxicology
2,789
Registered devices
16
Adverse events
7
Recalls
63
510(k) clearances
Devices with this code
INCUP — AMERICAN BIO MEDICA CORPORATIONToxCup Drug Screen Cup — BRANAN MEDICAL CORPORATIONSTATCUP® — MICRO DISTRIBUTING, L.CPROFILE®-V MEDTOXScan® — MEDTOX DIAGNOSTICS, INC.RTCII 1st gen. — AMERICAN BIO MEDICA CORPORATIONU-Screen — Instant Tech Subsidiary AcquisitionRTCII 2nd gen. — AMERICAN BIO MEDICA CORPORATIONQuickProfile™ Methadone Test Strip — LUMIQUICK DIAGNOSTICS, INC.Premier Bio-Cup & Bio-Dip — PREMIER BIOTECH, INCDrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.DrugSmart Cup — Twin Spirit Inc.Identify Home Drug Testing Device Test Cups — MEDICAL DISTRIBUTION GROUP INCEasy@Home Multi-Drug Test Cup (5 tests kit) — EASY HEALTHCARE CORPORATIONUCP — UCP BIOSCIENCES, INC.UCP Home Drug Screening Test Cups — MEDICAL DISTRIBUTION GROUP INCProScreen — Instant Technologies, Inc.DrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.DrugCheck — Express Diagnostic Int'l, Inc.DrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.PROFILE-II ER® — MEDTOX DIAGNOSTICS, INC.DrugCheck — EXPRESS DIAGNOSTICS INT'L, INC.Speedy Tests — SPEEDY SOLUTIONS LLCiCup® — Instant Technologies, Inc.DrugCheck — Express Diagnostic Int'l, 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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