FDA Device Registration & Listing · Sharonville, OH, US · Registration 3013684380
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| DJR | Enzyme Immunoassay, Methadone | Clinical Toxicology | Class 2 | 862.3620 | 2017-05-24 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | Class 2 | 862.3650 | 2017-05-24 |
| DNK | Thin Layer Chromatography, Morphine | Clinical Toxicology | Class 2 | 862.3640 | 2017-05-24 |
| JXN | Enzyme Immunoassay, Propoxyphene | Clinical Toxicology | Class 2 | 862.3700 | 2017-05-24 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | Clinical Toxicology | Class 2 | 862.3910 | 2017-05-24 |
| DJR | Enzyme Immunoassay, Methadone | Clinical Toxicology | Class 2 | 862.3620 | 2017-05-24 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | Class 2 | 862.3100 | 2017-05-24 |
| JXN | Enzyme Immunoassay, Propoxyphene | Clinical Toxicology | Class 2 | 862.3700 | 2017-05-24 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | Class 2 | 862.3650 | 2017-05-24 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | Class 2 | 862.3870 | 2017-05-24 |
| DJC | Thin Layer Chromatography, Methamphetamine | Clinical Toxicology | Class 2 | 862.3610 | 2017-05-24 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | Class 2 | 862.3250 | 2017-05-24 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | Clinical Toxicology | Class 2 | 862.3910 | 2017-05-24 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | Class U | N/A | 2017-05-24 |
| DNK | Thin Layer Chromatography, Morphine | Clinical Toxicology | Class 2 | 862.3640 | 2017-05-24 |
| DIS | Enzyme Immunoassay, Barbiturate | Clinical Toxicology | Class 2 | 862.3150 | 2017-05-24 |
| LAF | Gas Chromatography, Methamphetamine | Clinical Toxicology | Class 2 | 862.3610 | 2017-05-24 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | Class 2 | 862.3170 | 2017-05-24 |
| EXG | Bag, Urine Collecting, Ureterostomy | Gastroenterology, Urology | Class 1 | 876.5900 | 2021-01-11 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K131232 | Guangzhou Wondfo Biotech Co., Ltd. | WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) | 2013-05-31 |
| K153050 | Co-Innovation Biotech Co., Ltd. | Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard | 2016-04-26 |
| K151478 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo CR3 Keyless Split Sample Cup | 2015-07-01 |
| K150179 | Guangzhou Wondfo Biotech Co., Ltd. | CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids | 2015-02-25 |
| K112310 | Guangzhou Wondfo Biotech Co., Ltd. | WONDFO METHADONE URINE TEST,OPIATE TEST | 2011-09-08 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0029-2013 | Alere San Diego, Inc. | 2 | Triage TOX Drug Screen Panel, Model# 94400.
Product Usage:
The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. |
| Z-0006-2010 | Biosite Inc | 2 | Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG |
| Z-0007-2010 | Biosite Inc | 2 | Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG |
| Z-0008-2010 | Biosite Inc | 2 | Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG |
| Z-0009-2010 | Biosite Inc | 2 | Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3004987297 | UCP BIOSCIENCES, INC. | Milpitas, CA, US |
| 3005755244 | ARK DIAGNOSTICS INC | Fremont, CA, US |
| 3003795116 | ROCHE DIAGNOSTICS INTERNATIONAL LTD. | ROTKREUZ Zug, CH |
| 9610529 | ROCHE DIAGNOSTICS GMBH | PENZBERG Bavaria, DE |
| 1050155 | MEDTOX DIAGNOSTICS, INC. | BURLINGTON, NC, US |
3013684380 when referencing this establishment in official correspondence.