FDA Device Registration & Listing · San Diego, CA, US · Registration 2032364
Normalized identity and public registration information from FDA records.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | Clinical Chemistry | Class 2 | 862.1155 | 2006-08-30 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | Clinical Chemistry | Class 2 | 862.1155 | 2006-08-30 |
| DJG | Enzyme Immunoassay, Opiates | Clinical Toxicology | Class 2 | 862.3650 | 2006-08-30 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | Clinical Toxicology | Class 2 | 862.3910 | 2006-08-30 |
| DIS | Enzyme Immunoassay, Barbiturate | Clinical Toxicology | Class 2 | 862.3150 | 2006-08-30 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Clinical Toxicology | Class 2 | 862.3870 | 2006-08-30 |
| LAF | Gas Chromatography, Methamphetamine | Clinical Toxicology | Class 2 | 862.3610 | 2006-08-30 |
| DJR | Enzyme Immunoassay, Methadone | Clinical Toxicology | Class 2 | 862.3620 | 2006-08-30 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unknown | Class U | N/A | 2006-08-30 |
| DJC | Thin Layer Chromatography, Methamphetamine | Clinical Toxicology | Class 2 | 862.3610 | 2006-08-30 |
| DKZ | Enzyme Immunoassay, Amphetamine | Clinical Toxicology | Class 2 | 862.3100 | 2006-08-30 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Clinical Toxicology | Class 2 | 862.3170 | 2006-08-30 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Clinical Toxicology | Class 2 | 862.3250 | 2006-08-30 |
| NGE | Test, Luteinizing Hormone (Lh), Over The Counter | Clinical Chemistry | Class 1 | 862.1485 | 2026-06-05 |
No US Agent registered (Local establishment).
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K964108 | Direct Access Diagnostics | FACT PLUS PREGNANCY TEST | 1996-11-18 |
| K945514 | Princeton BioMeditech Corp. | LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG | 1995-02-10 |
| K150022 | Guangzhou Wondfo Biotech Co., Ltd. | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream | 2015-08-07 |
| K043443 | Guangzhou Wondfo Biotech Co., Ltd. | ONE STEP HCG URINE PREGNANCY TEST | 2005-04-08 |
| K173229 | Guangzhou Wondfo Biotech Co., Ltd. | Preview Digital Pregnancy Test | 2018-03-12 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0042-2024 | Universal Meditech Inc. | 2 | One Step Pregnancy Test REF 100-01 |
| Z-0006-05 | Abbott Health Products, Inc. | 2 | AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21 |
| 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. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 1051594 | CORDICA MEDICAL, INC. (Formally TEAM Technologies, Inc.) | MORRISTOWN, TN, US |
| 3007583565 | SPD DEVELOPMENT COMPANY LIMITED | Bedford, GB |
| 3012725363 | EASY HEALTHCARE CORPORATION | Darien, IL, US |
| 1649661 | GERMAINE LABORATORIES, INC. | SAN ANTONIO, TX, US |
| 3003741676 | ANDON HEALTH CO., LTD | TIANJIN, CN |
2032364 when referencing this establishment in official correspondence.