Guangzhou Wondfo Biotech Co., Ltd.
Guangzhou Guangdong, CN
GUANGZHOU WONDFO BIOTECH CO., LTD. appears in FDA device records in Guangzhou Guangdong, CN. FDA records list 43 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 43 510(k) clearances for Guangzhou Wondfo Biotech Co., Ltd. between 2005 and 2026. The busiest year on record is 2011, with 6. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 6 |
| 2012 | 6 |
| 2013 | 5 |
| 2014 | 6 |
| 2015 | 6 |
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 2 |
| 2020 | 1 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260065 | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx | NFT | Substantially Equivalent | |
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx | NFT | Substantially Equivalent | |
| K251289 | WELLlife COVID-19 Antigen Test Rx | QVF | Substantially Equivalent | |
| K241317 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) | QYT | Substantially Equivalent | |
| 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 | NGL | Substantially Equivalent | |
| K202567 | Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx | NFT | Substantially Equivalent | |
| K182701 | Wondfo T-Cup Multi-Drug Urine Test Cup | NFT | Substantially Equivalent | |
| K173229 | Preview Digital Pregnancy Test | LCX | Substantially Equivalent | |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) Test | KHE | Substantially Equivalent | |
| 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) | DIO | Substantially Equivalent | |
| K152495 | Wondfo Propoxyphene Urine Test | JXN | Substantially Equivalent | |
| 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 | LCX | Substantially Equivalent | |
| K151478 | Wondfo CR3 Keyless Split Sample Cup | DJG | Substantially Equivalent | |
| K150602 | CR3 Keyless Split Sample Cup Morphine - Methamphetamine | DNK | Substantially Equivalent | |
| K150179 | CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids | DJG | Substantially Equivalent | |
| K143535 | CR3 Keyless Split Sample Cup Secobarbital- Methadone | DIS | Substantially Equivalent | |
| K142609 | CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine | LFG | Substantially Equivalent | |
| K142044 | CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE | LCM | Substantially Equivalent | |
| K141532 | CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE | DKZ | Substantially Equivalent | |
| K140089 | CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO) | DJG | Substantially Equivalent | |
| K133968 | WONDFO MULTI-DRUG URINE TEST CUP, PANEL | DKZ | Substantially Equivalent | |
| K133343 | WONDFO RAPID STREP A TEST | GTY | Substantially Equivalent | |
| K132630 | WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300) | DJC | Substantially Equivalent | |
| K131754 | WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40) | DIO | Substantially Equivalent | |
| K131232 | WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100) | DJR | Substantially Equivalent | |
| K130665 | WONDOFO MULTI-DRUG URINE TEST CUP / PANEL | DJG | Substantially Equivalent | |
| K130055 | ACON BUP ONE STEP BUPRENORPHINE TEST STRIP | DJG | Substantially Equivalent | |
| K122961 | WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500) | DKZ | Substantially Equivalent | |
| K122904 | WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU; | DKZ | Substantially Equivalent | |
| K121987 | WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST | DKZ | Substantially Equivalent | |
| K121557 | WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST | LDJ | Substantially Equivalent | |
| K121166 | WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL | DIO | Substantially Equivalent | |
| K113624 | WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST | DJG | Substantially Equivalent | |
| K112071 | WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P | DIO | Substantially Equivalent | |
| K112236 | WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST | LAF | Substantially Equivalent | |
| K112395 | WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST | LFG | Substantially Equivalent | |
| K112310 | WONDFO METHADONE URINE TEST,OPIATE TEST | DJG | Substantially Equivalent | |
| K111560 | WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST | DKZ | Substantially Equivalent | |
| K110182 | CANNABINOIDS URINE TEST | LDJ | Substantially Equivalent | |
| K093175 | WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES | DJG | Substantially Equivalent | |
| K072500 | ONE STEP HCG URINE/SERUM TEST | DHA | Substantially Equivalent | |
| K050024 | ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS | DIS | Substantially Equivalent | |
| K043443 | ONE STEP HCG URINE PREGNANCY TEST | LCX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004635103 | 3004635103 | GUANGZHOU WONDFO BIOTECH CO., LTD. | No.8 Lizhishan Road, Science City, Huangpu District, Guangzhou Guangdong 510663 CN | 2026 | and 34 more, listed in full below |
| 3023322455 | 3023322455 | GUANGZHOU WONDFO BIOTECH CO., LTD. | Building 1, No.2 Huangqi Street, Songshan Lake Park, Dongguan Guangdong 523787 CN | 2026 | and 34 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method
- GTYAntigens, All Groups, Streptococcus Spp.
- NNKContainer, Specimen Mailer And Storage, Non-Sterile
- NNIContainer, Specimen, Non-Sterile
- QMNCovid-19 Multi-Analyte Antigen Device
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- JXNEnzyme Immunoassay, Propoxyphene
- LAFGas Chromatography, Methamphetamine
- QKEImmunoassay, Pregnanediol Glucuronide, Over The Counter
- MJZKit, Direct Antigen, Positive Control
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- SCAMulti-Analyte Respiratory Virus Antigen Detection Test
- QYTOver-The-Counter Covid-19 Antigen Test
- LFGRadioimmunoassay, Tricyclic Antidepressant Drugs
- KHEReagent, Occult Blood
- QVFSimple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
- DHASystem, Test, Human Chorionic Gonadotropin
- MRSTest System, Nicotine, Cotinine, Metabolites
- PUXTest, Amphetamine, Employment And Insurance Testing, Exempt
- NFTTest, Amphetamine, Over The Counter
- PUYTest, Barbiturate, Employment And Insurance Testing, Exempt
- PTHTest, Barbiturate, Over The Counter
- PUZTest, Benzodiazepine, Employment And Insurance Testing, Exempt
- NFVTest, Benzodiazepine, Over The Counter
- PVJTest, Cannabinoid, Employment And Insurance Testing, Exempt
- NFWTest, Cannabinoid, Over The Counter
- PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
- NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
- NGATest, Follicle Stimulating Hormone (Fsh), Over The Counter
- NGETest, Luteinizing Hormone (Lh), Over The Counter
- PVETest, Methadone, Employment And Insurance Testing, Exempt
- PTGTest, Methadone, Over The Counter
- PVDTest, Methamphetamine, Employment And Insurance Testing, Exempt
- NGGTest, Methamphetamine, Over The Counter
- PVHTest, Opiates, Employment And Insurance Testing, Exempt
- NGLTest, Opiates, Over The Counter
- QBFTest, Propoxyphene, Over The Counter
- QAWTest, Tricyclic Antidepressants, Over The Counter
- DJCThin Layer Chromatography, Methamphetamine
- DNKThin Layer Chromatography, Morphine
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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. | 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. | Class II | Open, Classified | |
| 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. | 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. | Class II | Open, Classified | |
| 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. | 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. | Class II | Open, Classified |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Guangzhou Wondfo Biotech Co., Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain