FDA Device Registration & Listing · SAN DIEGO, CA, US · Registration 3006048451
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | Microbiology | Class 2 | 866.3987 | 2025-09-15 |
| DJR | Enzyme Immunoassay, Methadone | Clinical Toxicology | Class 2 | 862.3620 | 2021-08-30 |
| DIS | Enzyme Immunoassay, Barbiturate | Clinical Toxicology | Class 2 | 862.3150 | 2021-08-30 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | Class 2 | 862.3870 | 2021-08-30 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | Class 2 | 862.3170 | 2021-08-30 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | Class U | N/A | 2021-08-30 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | Class 2 | 862.3100 | 2021-08-30 |
| LAF | Gas Chromatography, Methamphetamine | Clinical Toxicology | Class 2 | 862.3610 | 2021-08-30 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | Class 2 | 862.3250 | 2021-08-30 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | Class 2 | 862.3650 | 2021-08-30 |
| PVI | Test, Propoxyphene, Employment And Insurance Testing, Exempt | Clinical Toxicology | Class 2 | 862.3700 | 2026-02-03 |
| MPQ | Container, Specimen, Urine, Drugs Of Abuse, Over The Counter | Pathology | Class 1 | 864.3260 | 2006-12-12 |
| QBF | Test, Propoxyphene, Over The Counter | Clinical Toxicology | Class 2 | 862.3700 | 2026-02-03 |
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | Class 2 | 862.3650 | 2026-02-03 |
| NFW | Test, Cannabinoid, Over The Counter | Clinical Toxicology | Class 2 | 862.3870 | 2026-02-03 |
| NGM | Test, Phencyclidine (Pcp), Over The Counter | Unknown | Class U | N/A | 2026-02-03 |
| NGG | Test, Methamphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3610 | 2026-02-03 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | Clinical Toxicology | Class 2 | 862.3250 | 2026-02-03 |
| PTG | Test, Methadone, Over The Counter | Clinical Toxicology | Class 2 | 862.3620 | 2026-02-03 |
| PTH | Test, Barbiturate, Over The Counter | Clinical Toxicology | Class 2 | 862.3150 | 2026-02-03 |
| QAW | Test, Tricyclic Antidepressants, Over The Counter | Clinical Toxicology | Class 2 | 862.3910 | 2026-02-03 |
| NFT | Test, Amphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3100 | 2026-02-03 |
| NFV | Test, Benzodiazepine, Over The Counter | Clinical Toxicology | Class 2 | 862.3170 | 2026-02-03 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | Class 2 | 862.1155 | 2026-02-03 |
| PVH | Test, Opiates, Employment And Insurance Testing, Exempt | Clinical Toxicology | Class 2 | 862.3650 | 2026-02-03 |
| PVJ | Test, Cannabinoid, Employment And Insurance Testing, Exempt | Clinical Toxicology | Class 2 | 862.3870 | 2026-02-03 |
| PVG | Test, Morphine, Employment And Insurance Testing, Exempt | Clinical Toxicology | Class 2 | 862.3640 | 2026-02-03 |
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 |
| 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 |
| 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-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 |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3005174594 | NANO-DITECH CORPORATION | Cranbury, NJ, US |
| 3023372670 | Diversified Synergies, LLC | Detroit, MI, US |
| 1221359 | Abbott Diagnostics Scarborough, Inc. | Scarborough, ME, US |
| 3008517993 | ZHEJIANG ORIENT GENE BIOTECH | Huzhou Zhejiang, CN |
| 3016850770 | BIOHIT HEALTHCARE (HEFEI) CO., LTD. | Hefei Anhui, CN |
3006048451 when referencing this establishment in official correspondence.