FDA Device Registration & Listing · Vineyard New South Wales, AU · Registration 3031697086
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| NFW | Test, Cannabinoid, Over The Counter | Clinical Toxicology | Class 2 | 862.3870 | 2025-05-06 |
| PTH | Test, Barbiturate, Over The Counter | Clinical Toxicology | Class 2 | 862.3150 | 2025-05-06 |
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | Class 2 | 862.3650 | 2025-05-06 |
| NGM | Test, Phencyclidine (Pcp), Over The Counter | Unknown | Class U | N/A | 2025-05-06 |
| NFT | Test, Amphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3100 | 2025-05-06 |
| NGG | Test, Methamphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3610 | 2025-05-06 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | Clinical Toxicology | Class 2 | 862.3250 | 2025-05-06 |
| NFV | Test, Benzodiazepine, Over The Counter | Clinical Toxicology | Class 2 | 862.3170 | 2025-05-06 |
| PTG | Test, Methadone, Over The Counter | Clinical Toxicology | Class 2 | 862.3620 | 2025-05-06 |
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | Class 2 | 862.3650 | 2025-05-06 |
| PTH | Test, Barbiturate, Over The Counter | Clinical Toxicology | Class 2 | 862.3150 | 2025-05-06 |
| NFW | Test, Cannabinoid, Over The Counter | Clinical Toxicology | Class 2 | 862.3870 | 2025-05-06 |
| NGM | Test, Phencyclidine (Pcp), Over The Counter | Unknown | Class U | N/A | 2025-05-06 |
| QBF | Test, Propoxyphene, Over The Counter | Clinical Toxicology | Class 2 | 862.3700 | 2025-05-06 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | Clinical Toxicology | Class 2 | 862.3250 | 2025-05-06 |
| NFT | Test, Amphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3100 | 2025-05-06 |
| NGG | Test, Methamphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3610 | 2025-05-06 |
| QAW | Test, Tricyclic Antidepressants, Over The Counter | Clinical Toxicology | Class 2 | 862.3910 | 2025-05-06 |
| PTG | Test, Methadone, Over The Counter | Clinical Toxicology | Class 2 | 862.3620 | 2025-05-06 |
| NFV | Test, Benzodiazepine, Over The Counter | Clinical Toxicology | Class 2 | 862.3170 | 2025-05-06 |
| NFT | Test, Amphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3100 | 2025-05-06 |
| NGM | Test, Phencyclidine (Pcp), Over The Counter | Unknown | Class U | N/A | 2025-05-06 |
| NFV | Test, Benzodiazepine, Over The Counter | Clinical Toxicology | Class 2 | 862.3170 | 2025-05-06 |
| PTG | Test, Methadone, Over The Counter | Clinical Toxicology | Class 2 | 862.3620 | 2025-05-06 |
| NGG | Test, Methamphetamine, Over The Counter | Clinical Toxicology | Class 2 | 862.3610 | 2025-05-06 |
| QBF | Test, Propoxyphene, Over The Counter | Clinical Toxicology | Class 2 | 862.3700 | 2025-05-06 |
| NGL | Test, Opiates, Over The Counter | Clinical Toxicology | Class 2 | 862.3650 | 2025-05-06 |
| NFY | Test, Cocaine And Cocaine Metabolites, Over The Counter | Clinical Toxicology | Class 2 | 862.3250 | 2025-05-06 |
| QAW | Test, Tricyclic Antidepressants, Over The Counter | Clinical Toxicology | Class 2 | 862.3910 | 2025-05-06 |
| PTH | Test, Barbiturate, Over The Counter | Clinical Toxicology | Class 2 | 862.3150 | 2025-05-06 |
| NFW | Test, Cannabinoid, Over The Counter | Clinical Toxicology | Class 2 | 862.3870 | 2025-05-06 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | Clinical Chemistry | Class 1 | 862.2170 | 2025-05-04 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | Class 2 | 862.3170 | 2025-05-06 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | Clinical Toxicology | Class 2 | 862.3910 | 2025-05-06 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | Class 2 | 862.3650 | 2025-05-06 |
| DIS | Enzyme Immunoassay, Barbiturate | Clinical Toxicology | Class 2 | 862.3150 | 2025-05-06 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | Class 2 | 862.3870 | 2025-05-06 |
| JXN | Enzyme Immunoassay, Propoxyphene | Clinical Toxicology | Class 2 | 862.3700 | 2025-05-06 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | Class 2 | 862.3100 | 2025-05-06 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | Class U | N/A | 2025-05-06 |
| LAF | Gas Chromatography, Methamphetamine | Clinical Toxicology | Class 2 | 862.3610 | 2025-05-06 |
| DJR | Enzyme Immunoassay, Methadone | Clinical Toxicology | Class 2 | 862.3620 | 2025-05-06 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | Class 2 | 862.3250 | 2025-05-06 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K241741 | Guangzhou Wondfo Biotech Co., Ltd. | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel | 2024-07-16 |
| K252550 | Guangzhou Wondfo Biotech Co., Ltd. | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx | 2025-11-18 |
| K202567 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx | 2020-09-25 |
| K260065 | Guangzhou Wondfo Biotech Co., Ltd. | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx | 2026-04-28 |
| K182701 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo T-Cup Multi-Drug Urine Test Cup | 2018-12-03 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0038-2020 | Vital Scientific N.V. 24, Kanaalweg Postbus 100 Dieren Netherlands | 1 | V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring. |
| 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 |
|---|---|---|
| 3003917514 | BTNX Inc. | Pickering Ontario, CA |
| 3008741972 | Lochness Medical | Buffalo, NY, US |
| 3009585529 | ASSURE TECH. (HANGZHOU) CO., LTD. | Hangzhou Zhejiang, CN |
| 3024463179 | ACESO LABORATORIES INC. | Chino, CA, US |
| 3043127647 | Hangzhou AllTest Biotech Co.,Ltd | Hangzhou Zhejiang, CN |
3031697086 when referencing this establishment in official correspondence.