Guangzhou Wondfo Biotech Co., Ltd.
Guangzhou Wondfo Biotech Co., Ltd. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2026, with 3 FDA device recalls on record.
Top product codes for Guangzhou Wondfo Biotech Co., Ltd.
FDA recalls by Guangzhou Wondfo Biotech Co., Ltd.
- 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.
- 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.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Guangzhou Wondfo Biotech Co., Ltd.
- K260065 — SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx
- K252550 — SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx
- K251289 — WELLlife COVID-19 Antigen Test Rx
- K241317 — Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
- K241741 — SAFElife Fentanyl Urine Home Test (Cassette) +3 more
- K202567 — Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx
- K182701 — Wondfo T-Cup Multi-Drug Urine Test Cup
- K173229 — Preview Digital Pregnancy Test
- K162333 — Wondfo One Step Fecal Occult Blood (FOB) Test
- 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)
- K152495 — Wondfo Propoxyphene Urine Test
- 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
- K151478 — Wondfo CR3 Keyless Split Sample Cup
- K150602 — CR3 Keyless Split Sample Cup Morphine - Methamphetamine
- K150179 — CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
- K143535 — CR3 Keyless Split Sample Cup Secobarbital- Methadone
- K142609 — CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine
- K142044 — CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE
- K141532 — CR3 KEYLESS SPLIT SAMPLE CUP AMPHETAMINE-COCAINE
- K140089 — CR3 KEYLESS SPLIT SAMPLE CUP(OPI-BZO)
- K133968 — WONDFO MULTI-DRUG URINE TEST CUP, PANEL
- K133343 — WONDFO RAPID STREP A TEST
- K132630 — WONDFO OXAZEPAM URINE TEST (BZO 200) AND WONDFO METHAMPHETAMINE URINE TEST (MET 300)
- K131754 — WONDFO COCAINE URINE TEST (COC 100), WONDFO CANNABINOIDS URINE TEST (THC 40)
- K131232 — WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)
- K130665 — WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
- K130055 — ACON BUP ONE STEP BUPRENORPHINE TEST STRIP
- K122961 — WONDFO AMPHETAMINE URINE TEST (AMP 300), WONDFO METHAMPHETAMINE URINE TEST (MET 500)
- K122904 — WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU
- K121987 — WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST
- K121557 — WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST
- K121166 — WONDFO MULTI-DRUG URINE TEST CUP WONDFO MULTI-DRUG URINE TEST PANEL
- K113624 — WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST
- K112071 — WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P
- K112236 — WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST
- K112395 — WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST
- K112310 — WONDFO METHADONE URINE TEST,OPIATE TEST
- K111560 — WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST
- K110182 — CANNABINOIDS URINE TEST
- K093175 — WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES
- K072500 — ONE STEP HCG URINE/SERUM TEST
- K050024 — ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS
- K043443 — ONE STEP HCG URINE PREGNANCY TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.