Home › Device types › DLJ
Calibrators, Drug Specific
FDA product code DLJ · Class 2 · Clinical Toxicology
604
Registered devices
21
Adverse events
5
Recalls
123
510(k) clearances
Devices with this code
Oral Fluid 6-Acetylmorphine Calibrator, Negative Calibrator — LIN-ZHI INTERNATIONAL, INC.QMS Vancomycin Immunoassay — Microgenics CorporationHydrocodone 300 DAU Calibrator, Low Calibrator — LIN-ZHI INTERNATIONAL, INC.ARK™ Methotrexate Calibrator — ARK DIAGNOSTICS INCPointe Ecstasy (MDMA) Calibrator (100 ng/mL) Low — HORIBA INSTRUMENTS INCORPORATEDHydrocodone 100 DAU Calibrator, Cutoff Calibrator — LIN-ZHI INTERNATIONAL, INC.ARK™ Ethyl Glucuronide 1000 Cutoff Calibrator — ARK DIAGNOSTICS INCCAROLINA LIQUID CHEMISTRIES CORP.® BENZ BENZODIAZEPINE CC418 — CAROLINA LIQUID CHEMISTRIES CORPORATIONCAROLINA LIQUID CHEMISTRIES CORP.® METH RGT. KIT ST327 — CAROLINA LIQUID CHEMISTRIES CORPORATIONDRI Ecstasy 1000 ng/mL Calibrator — Microgenics CorporationCannabinoids DAU Calibrator/Control, Calibrator/Control — LIN-ZHI INTERNATIONAL, INC.Phencyclidine DAU Calibrator, Cutoff Calibrator — LIN-ZHI INTERNATIONAL, INC.Oral Fluid Amphetamine Calibrator, Intermediate Calibrator — LIN-ZHI INTERNATIONAL, INC.MyCare Psychiatry — SALADAX BIOMEDICAL, INC.Immunalysis — IMMUNALYSIS CORPImmunalysis — IMMUNALYSIS CORPARK™ Ketamine Cutoff Calibrator — ARK DIAGNOSTICS INCOpiate DAU Calibrator, Intermediate Calibrator — LIN-ZHI INTERNATIONAL, INC.ARK™ Pregabalin Urine Calibrator — ARK DIAGNOSTICS INCOral Fluid Methamphetamine Calibrator, High Calibrator — LIN-ZHI INTERNATIONAL, INC.Immunalysis — IMMUNALYSIS CORPImmunalysis — IMMUNALYSIS CORPOral Fluid 6-Acetylmorphine Calibrator/Control, Low Calibrator/Level 1 Control — LIN-ZHI INTERNATIONAL, INC.Pointe Amphetamines 500 Calibrator (MAMP 500 ng/mL) — HORIBA INSTRUMENTS INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-04-14 | Ortho-Clinical Diagnostics, Inc. | Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing |
| 2014-02-06 | Lin-Zhi International Inc | Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentratio |
| 2011-11-11 | Microgenics Corp | Reports that third party control material for 4 lots of Tobramycin Calibrators that are recovering low and outside of the published range. |
| 2011-06-08 | Microgenics Corp | Complaint from the sole distributor that the third party control material is recovering high, and outside the published range. |
| 2010-09-13 | Abbott Laboratories | The assay may produce falsely elevated vancomycin results. Inaccurate test results may result in inappropriate patient treatment. |
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