GUANGZHOU WONDFO BIOTECH CO., LTD.

Entity profile compiled from public source records

Public Record Profile Registrations: 2 510(k) filings: 43 Recalls: 3

Known Identifiers & Locations

FEI Numbers 3004635103, 3023322455
Owner Operator Numbers 9064561
Locations Covered Guangzhou Guangdong, CN

Registered Establishments (2)

Registration # Establishment Name Location Establishment Type(s) Action
3004635103 GUANGZHOU WONDFO BIOTECH CO., LTD. Guangzhou Guangdong, CN Manufacture Medical Device View Details
3023322455 GUANGZHOU WONDFO BIOTECH CO., LTD. Guangzhou Guangdong, CN Complaint File Establishment per 21 CFR 820.198 View Details

510(k) Premarket Notifications (43)

Submission # Device Name Decision Date Decision Description Action
K043443 ONE STEP HCG URINE PREGNANCY TEST 2005-04-08 Substantially Equivalent View Details
K050024 ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS 2005-11-17 Substantially Equivalent View Details
K072500 ONE STEP HCG URINE/SERUM TEST 2009-04-21 Substantially Equivalent View Details
K093175 WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES 2010-08-25 Substantially Equivalent View Details
K110182 CANNABINOIDS URINE TEST 2011-05-20 Substantially Equivalent View Details
K111560 WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST 2011-07-15 Substantially Equivalent View Details
K112071 WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P 2011-09-23 Substantially Equivalent View Details
K112236 WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST 2011-09-19 Substantially Equivalent View Details
K112310 WONDFO METHADONE URINE TEST,OPIATE TEST 2011-09-08 Substantially Equivalent View Details
K112395 WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST 2011-09-09 Substantially Equivalent View Details
K113624 WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST 2012-03-12 Substantially Equivalent View Details
K121166 WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL 2012-05-08 Substantially Equivalent View Details
K121557 WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST 2012-07-25 Substantially Equivalent View Details
K121987 WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST 2012-08-01 Substantially Equivalent View Details
K122904 WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; 2012-11-15 Substantially Equivalent View Details
K122961 WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) 2012-12-21 Substantially Equivalent View Details
K130055 ACON BUP ONE STEP BUPRENORPHINE TEST STRIP 2013-02-14 Substantially Equivalent View Details
K130665 WONDOFO MULTI-DRUG URINE TEST CUP / PANEL 2013-04-09 Substantially Equivalent View Details
K131232 WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) 2013-05-31 Substantially Equivalent View Details
K131754 WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) 2013-07-31 Substantially Equivalent View Details
K132630 WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) 2013-09-27 Substantially Equivalent View Details
K133343 WONDFO RAPID STREP A TEST 2014-01-31 Substantially Equivalent View Details
K133968 WONDFO MULTI-DRUG URINE TEST CUP, PANEL 2014-02-25 Substantially Equivalent View Details
K140089 CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) 2014-04-08 Substantially Equivalent View Details
K141532 CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE 2014-07-14 Substantially Equivalent View Details
K142044 CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE 2014-08-25 Substantially Equivalent View Details
K142609 CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine 2014-12-18 Substantially Equivalent View Details
K143535 CR3 Keyless Split Sample Cup Secobarbital- Methadone 2015-01-13 Substantially Equivalent View Details
K150022 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 Substantially Equivalent View Details
K150179 CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids 2015-02-25 Substantially Equivalent View Details
K150602 CR3 Keyless Split Sample Cup Morphine - Methamphetamine 2015-04-07 Substantially Equivalent View Details
K151478 Wondfo CR3 Keyless Split Sample Cup 2015-07-01 Substantially Equivalent View Details
K152495 Wondfo Propoxyphene Urine Test 2015-11-23 Substantially Equivalent View Details
K161214 Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) 2016-06-27 Substantially Equivalent View Details
K162333 Wondfo One Step Fecal Occult Blood (FOB) Test 2017-05-14 Substantially Equivalent View Details
K173229 Preview Digital Pregnancy Test 2018-03-12 Substantially Equivalent View Details
K182701 Wondfo T-Cup Multi-Drug Urine Test Cup 2018-12-03 Substantially Equivalent View Details
K202567 Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx 2020-09-25 Substantially Equivalent View Details
K241317 Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) 2024-09-30 Substantially Equivalent View Details
K241741 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 Substantially Equivalent View Details
K251289 WELLlife COVID-19 Antigen Test Rx 2025-10-22 Substantially Equivalent View Details
K252550 SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx 2025-11-18 Substantially Equivalent View Details
K260065 SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx 2026-04-28 Substantially Equivalent View Details

FDA Recall History (3)

Recall # Product Description Initiation Date Status Action
Z-2787-2018 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. Reason: GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device could cause the foam tip to become dislodged in the user's mouth creating a choking hazard. 2018-05-18 Open, Classified View Details
Z-2788-2018 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. Reason: GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device could cause the foam tip to become dislodged in the user's mouth creating a choking hazard. 2018-05-18 Open, Classified View Details
Z-2789-2018 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. Reason: GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collection device could cause the foam tip to become dislodged in the user's mouth creating a choking hazard. 2018-05-18 Open, Classified View Details

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