FDA Device Registration & Listing · Cincinnati, OH, US · Registration 3036649420
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| DIS | Enzyme Immunoassay, Barbiturate | Clinical Toxicology | Class 2 | 862.3150 | 2025-06-27 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | Class 2 | 862.3100 | 2025-06-27 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | Class U | N/A | 2025-06-27 |
| DJC | Thin Layer Chromatography, Methamphetamine | Clinical Toxicology | Class 2 | 862.3610 | 2025-06-27 |
| DJR | Enzyme Immunoassay, Methadone | Clinical Toxicology | Class 2 | 862.3620 | 2025-06-27 |
| JXN | Enzyme Immunoassay, Propoxyphene | Clinical Toxicology | Class 2 | 862.3700 | 2025-06-27 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | Class 2 | 862.3870 | 2025-06-27 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | Class 2 | 862.3170 | 2025-06-27 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | Class 2 | 862.3650 | 2025-06-27 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | Class 2 | 862.3250 | 2025-06-27 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | Clinical Toxicology | Class 2 | 862.3910 | 2025-06-27 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | Clinical Toxicology | Class 2 | 862.3250 | 2026-01-14 |
| NFT | Test, Amphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3100 | 2026-01-14 |
| NGM | Test, Phencyclidine (Pcp), Over The Counter | Unknown | Class U | N/A | 2026-01-14 |
| NGG | Test, Methamphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3610 | 2026-01-14 |
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | Class 2 | 862.3650 | 2026-01-14 |
| NFV | Test, Benzodiazepine, Over The Counter | Clinical Toxicology | Class 2 | 862.3170 | 2026-01-14 |
| QBF | Test, Propoxyphene, Over The Counter | Clinical Toxicology | Class 2 | 862.3700 | 2026-01-14 |
| PTG | Test, Methadone, Over The Counter | Clinical Toxicology | Class 2 | 862.3620 | 2026-01-14 |
| NFW | Test, Cannabinoid, Over The Counter | Clinical Toxicology | Class 2 | 862.3870 | 2026-01-14 |
| QAW | Test, Tricyclic Antidepressants, Over The Counter | Clinical Toxicology | Class 2 | 862.3910 | 2026-01-14 |
| PTH | Test, Barbiturate, Over The Counter | Clinical Toxicology | Class 2 | 862.3150 | 2026-01-14 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K833577 | Syva Co. | MODIF. OF EMIT URINE BARBITURATE | 1984-01-26 |
| K143535 | Guangzhou Wondfo Biotech Co., Ltd. | CR3 Keyless Split Sample Cup Secobarbital- Methadone | 2015-01-13 |
| K050024 | Guangzhou Wondfo Biotech Co., Ltd. | ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS | 2005-11-17 |
| K920417 | Instrumentation Laboratory CO | IL TEST BARBITURATE, 35289 | 1992-04-24 |
| K970265 | Drial Consultants, Inc. | ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST | 1997-04-08 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-2787-2018 | Guangzhou Wondfo Biotech Co., Ltd. | 2 | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO,COC20,METSO, OPl40,OXY20,THC2S)
Product Usage:
T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive. |
| Z-2788-2018 | Guangzhou Wondfo Biotech Co., Ltd. | 2 | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, BZ030,COC20,MDMA100,METSO, MTD30,OPl40,OXY20, THC2S)
Product Usage:
T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive. |
| Z-2789-2018 | Guangzhou Wondfo Biotech Co., Ltd. | 2 | TCube One Step Multi-Drug Oral Fluid Test Cube (AMPSO, BARGO, SUPS, BZ030, COC20,MDMAlOO, METSO, OPl40,OXY20,THC2S)
Product Usage:
T-Cube One Step Multi-Drug Oral Fluid Test Cube is a rapid oral fluid screening test. The test is a lateral flow, one-step immunoassay for the qualitative detection of specific drugs and their metabolites in human oral fluid at the following cut off concentrations for use in employment and insurance testing. The assay provides a qualitative, preliminary test result. A more specific analytical method must be used in order to obtain a confirmed result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) are preferred confirmatory methods. Professional judgment should be applied to any drug test result, particularly when preliminary results are positive. |
| 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 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3004987297 | UCP BIOSCIENCES, INC. | Milpitas, CA, US |
| 1220972 | MEDICA CORP. | BEDFORD, MA, US |
| 9610529 | ROCHE DIAGNOSTICS GMBH | PENZBERG Bavaria, DE |
| 3008852306 | Chemtron Biotech, Inc. | San Diego, CA, US |
| 2432235 | Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, US |
3036649420 when referencing this establishment in official correspondence.