Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008987086

FEI Number

3008987086

Entity Name

CHANGCHUN WANCHENG BIO-ELECTRON CO., LTD.

City/State/Country

Changchun Jilin, CN

Establishment Address

No. 2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, Jilin, Changchun Jilin 130000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Changchun Wancheng Bio-Electron Co., Ltd. (Owner Number: 10049606)

Owner / Operator Contact Address

No. 2336, Tianwei Road, Beihu Science and Technology Development Zone, Changchun, Jilin, Changchun, CN-JL 130000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Salmonella test (fluorescence analysis) Salmonella (fluorescence analysis) Salmonella test (colloidal gold) get Tested Salmonella Test Calcium Ovulation Urine Test Strip Male Sperm Count Test TREA Male Fertility Test get Tested sperm test Fericare Male Fertility Test Exploro Highly Male Fertility/Sperm Concentration Test Palinoia ProGenix male fertility test Atifer Fertility Sperm Count Test for Men Acid Ascorbic Acid Test Ascorbate diazonium colorimetry, urobilinogen (urinary, non-quant.) Urinary Test Non-Quant., Diazonium colorimetry; Urobilinogen Uric Acid test Urinary Test Non-Quant., Nitroprusside Ketone Test Strip ketones (urinary, non-quant.) Escherichia coli test (powder) Escherichia coli test (colloidal gold) antisera, all types, escherichia coli Urine Test Strip for Albumin-to-Creatinine Ratio Urinary Test Non-Quant., Protein Micro Albumin Accurature Multi-drug Urine Test Cup;Accurature Multi-drug Urine Test Dip Card Multi-drug Urine Test Cup;Multi-drug Urine Test Dip Card; URS 3N teststrip URIMED Strips nitrite Urinary Test Non-Quant Nitric oxide test DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT) qualitative chemical reactions, urinary calculi (stone) Vaginal PH Test Strip Automated Urinalysis system Semi-Automatic Urine Analyzer specific gravity Free Radical test aflatoxin (colloidal gold) Urine Salinity test Test For The Concentration of Ortho-phthalaldehyde test JNW Direct Lead Test Swabs - 10 pack Lead Test Swab Lead test (colloidal gold) Urine Magnesium test Urine Zinc Test; VC Total chlorine, Free chlorine, Bromine, Nitrate, Nitrite, hydrogen sulfide, manganese, sulfate, zinc, sodium chloride JNW Chlorine Test Strips - 100 Pack Fluoride, Chromium/Cr, Copper, Lead, Hg, Iron, Cyanuric acid, pH, Hardness, Total alkalinity, Carbonate root Creatinine Urinary Test Non-Quant, AZO-DYES colorimetric, bilirubin & its conjugates (urinary, non-quant.) One step FSH rapid test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GOO	Antisera, Fluorescent, All Globulins, Salmonella Spp.	Microbiology	Class 2	866.3550	2021-12-30
IGD	Solution, Formol Calcium	Pathology	Class 1	864.4010	2017-12-10
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2021-12-29
DFQ	Sperm, Antigen, Antiserum, Control	Immunology	Class 1	866.5800	2021-12-29
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2015-06-27
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2015-06-27
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2021-12-30
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2015-06-27
GNA	Antisera, All Types, Escherichia Coli	Microbiology	Class 1	866.3255	2021-12-30
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2015-06-27
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2024-12-30
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2024-12-30
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2024-12-30
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2024-12-30
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2024-12-30
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2024-12-30
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2024-12-30
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2024-12-30
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2024-12-30
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2024-12-30
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2015-06-27
JNQ	Qualitative Chemical Reactions, Urinary Calculi (Stone)	Clinical Chemistry	Class 1	862.1780	2023-01-10
LNW	Paper, Obstetric Ph	Clinical Chemistry	Class 1	862.1550	2021-12-29
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2015-06-27
KSL	Solution, Copper Sulfate For Specific Gravity Determinations	Hematology	Class 1	864.9320	2018-03-21
JXA	Kit, Screening, Urine	Microbiology	Class 1	866.2660	2021-12-30
JRS	Purifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)	Clinical Chemistry	Class 1	862.2050	2022-12-09
JLA	Conversion To Creatinine, Creatine	Clinical Chemistry	Class 1	862.1210	2017-12-10
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2015-06-27
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2024-09-18

Official Correspondent

Yanru Zhang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Changchun Wancheng Bio-Electron 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
K830679	Dow Instruments & Reagents, Inc.	URIC ACID COLORIMETRIC DETERMINATION	1983-04-06
K885053	Biotrol, USA, Inc.	BIOTROL URINE PROTEINS REAGENT	1989-01-30
K833577	Syva Co.	MODIF. OF EMIT URINE BARBITURATE	1984-01-26
K143535	Guangzhou Wondfo Biotech Co., Ltd.	CR3 Keyless Split Sample Cup Secobarbital- Methadone	2015-01-13
K050024	Guangzhou Wondfo Biotech Co., Ltd.	ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYS	2005-11-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0043-2024	Universal Meditech Inc.	1	One Step Ovulation Test REF 200-01
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 3008987086. Last updated year: 2026. Please use registration number 3008987086 when referencing this establishment in official correspondence.