Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017904598

FEI Number

3017904598

Entity Name

Guangzhou Decheng Biotechnology Co., Ltd.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, Science City, Huangpu District, Guangzhou Guangdong 510663, CN

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Guangzhou Decheng biotechnology co., Ltd. (Owner Number: 10079520)

Owner / Operator Contact Address

Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, Science City, Huangpu District, Guangzhou, CN-GD 510663, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

UScreen Oral® Saliva Drug Test Pen Amazewell D-Pen Oral Fluid Drug Test Amazewell Lollipop Oral Fluid Drug Test MGC HEALTH D-PEN ORAL FLUID DRUG TEST Wondfo Pregnancy Test pregmate® PREGNANCY Test Strips kozekoze Pregnancy Test MissLan® Pregnancy Rapid Test Strip MissLan® Pregnancy Rapid Test (Strip) exchange select Analog Pregnancy Rapid Test Walgreens Pregnancy Test Strips MissLan® Pregnancy Rapid Test (Midstream) Pregnancy Test Strip easy@Home® PREGNANCY TEST Amazewell Pregnancy Rapid Test Strip MGC HEALTH ANALOG PREGNANCY RAPID TEST Amazewell Pregnancy Rapid Test Midstream MissLan® Pregnancy Rapid Test Midstream pregmate® Pregnancy Midstream Test Pregnancy Rapid Test Midstream CVS PREGNANCY TEST STRIPS Hy-Vee® Analog Pregnancy Rapid Test SURESIGN Pregnancy Rapid Test Pregnancy Rapid Test (Strip) Amazewell D-Pen Oral Fluid Drug Test MGC HEALTH D-PEN ORAL FLUID DRUG TEST UScreen Oral® Saliva Drug Test Pen CVSHealth® 6 Drugs Oral Test Kit Amazewell Lollipop Oral Fluid Drug Test Fentanyl Urine Test easy@Home® EARLY DETECTION PREGNANCY TEST One Step® HCG Early Rapid Pregnancy Strips Amazewell Early Detection Pregnancy Test Strip MissLan® Early Detection Pregnancy Test Strip MissLan® Early Detection Pregnancy Test Cassette kozekoze Early Detection Pregnancy Test MissLan® Early Detection Pregnancy Test Midstream Amazewell Early Detection Pregnancy Test Midstream INDICAID Early Detection Pregnancy Test Strip exchange select Early Detection Pregnancy Test 6 Days Sonner SURESIGN Early Detection Pregnancy Test MGC HEALTH EARLY DETECTION PREGNANCY TEST Early Detection Pregnancy Test One Step® HCG Early Rapid Pregnancy Midstream Test Hy-Vee® 6 Days Sooner/Early Detection Pregnancy Test Early Detection Pregnancy Test Cassette equate 6 Days Sooner Pregnancy Test Strip UScreen Oral® Saliva Drug Test Pen Carethetic® PdG Urine Test easy@Home® PdG Urine Test One Step® Progesterone (PdG) Urine Test Strip PdG Urine Test Strip MGC HEALTH D-PEN ORAL FLUID DRUG TEST Amazewell D-Pen Oral Fluid Drug Test Amazewell Lollipop Oral Fluid Drug Test UScreen Oral® Saliva Drug Test Pen SURESIGN Menopause (FSH) Rapid Test VeriQuick® At Home Menopause Test Strip easy@Home® FSH Urine Test PREGMATE® MENOPAUSE TEST STRIPS MGC HEALTH DIGITAL PREGNANCY RAPID TEST MissLan® Digital Pregnancy Rapid Test Amazewell Digital Pregnancy Rapid Test SURESIGN Digital Pregnancy Rapid Test Digital Pregnancy Rapid Test BEB® Digital Pregnancy Rapid Test BABYlife DIGITAL PREGNANCY TEST pregmate Digital Pregnancy Test exchange select Digital Pregnancy Rapid Test Hy-Vee® Digital Pregnancy Rapid Test NOBLE Multi-Drug Urine Test Dipcard EZCHECK® Marijuana (THC) Urine Test EZCHECK® Multi-Drug Urine Test Dipcard Amazewell Single Drug Urine Test Dipcard Dochek® Multi-Drug Urine Test Dipcard Amazewell Multi-Drug Urine Test Dipcard UScreen Multi-Drug Urine Test Dipcard Dochek® Multi-Drug Urine Test Dipcard Rx MYM Multi-Drug Urine Test Dipcard IDT Multi-Drug Urine Test Dipcard One Step® 7-PANEL MULTI DRUG URINE TEST Amazewell D-Pen Oral Fluid Drug Test UScreen Oral® Saliva Drug Test Pen MGC HEALTH D-PEN MINI COC ORAL FLUID TEST MGC HEALTH D-PEN ORAL FLUID DRUG TEST Amazewell Lollipop Oral Fluid Drug Test CVSHealth® 6 Drugs Oral Test Kit CVSHealth® 1 Drug Oral Test Kit Amazewell D-Pen Mini THC Oral Fluid Test MGC HEALTH D-PEN ORAL FLUID DRUG TEST Amazewell Lollipop Oral Fluid Drug Test UScreen Oral® Saliva Drug Test Pen MGC HEALTH D-PEN MINI THC ORAL FLUID TEST Amazewell D-Pen Oral Fluid Drug Test CVSHealth® 6 Drugs Oral Test Kit Amazewell Lollipop Oral Fluid Drug Test Amazewell D-Pen Oral Fluid Drug Test UScreen Oral® Saliva Drug Test Pen MGC HEALTH D-PEN ORAL FLUID DRUG TEST CVSHealth® 6 Drugs Oral Test Kit UScreen Oral® Saliva Drug Test Pen Amazewell D-Pen Mini COT Oral Fluid Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PVE	Test, Methadone, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3620	2023-12-15
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2023-04-13
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3610	2023-12-15
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2026-03-22
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2024-07-21
PUZ	Test, Benzodiazepine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3170	2024-07-21
QKE	Immunoassay, Pregnanediol Glucuronide, Over The Counter	Clinical Chemistry	Class 1	862.1620	2023-06-28
PUY	Test, Barbiturate, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3150	2023-12-15
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2025-08-26
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2023-01-11
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2024-05-26
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2024-05-26
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2024-05-26
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2024-05-26
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2024-05-26
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2024-05-26
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2024-05-26
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2024-05-26
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2024-05-26
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2024-05-26
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2024-05-26
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2024-05-26
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2024-05-26
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2024-05-26
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-05-26
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2024-05-26
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2024-05-26
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2024-05-26
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2024-05-26
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2024-05-26
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2024-05-26
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2024-05-26
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3250	2023-09-03
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3870	2023-08-30
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3650	2023-12-15
MRS	Test System, Nicotine, Cotinine, Metabolites	Clinical Toxicology	Class 1	862.3220	2023-08-30

Official Correspondent

haisheng Hu

US Agent Details

Joe Xia Business: LSI International Inc Email: jxia@lsi-consulting.org Phone: (240) 5057880

Related Public Records

Same Entity

Guangzhou Decheng biotechnology co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0042-2024	Universal Meditech Inc.	2	One Step Pregnancy Test REF 100-01
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017904598. Last updated year: 2026. Please use registration number 3017904598 when referencing this establishment in official correspondence.