Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005345870

FEI Number

3005345870

Entity Name

W.H.P.M. Bioresearch & Technology Co., Ltd.

City/State/Country

BEIJING, CN

Establishment Address

Building 9, No.9 Tianfu Street, Daxing District, BEIJING 102629, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

W.H.P.M. Bioresearch & Technology Co., Ltd. (Owner Number: 9076940)

Owner / Operator Contact Address

Building 9, No.9 Tianfu Street,, Daxing District, BEIJING, CN-BJ 102629, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

First Sign Drug of Abuse Screening Test STAT Dip One Step Drug Test STAT Cup One Step Drug Test STAT Cup II One Step Drug Test STAT Cassette One Step Drug Test First Sign Drug of Abuse Dip Card Test First Sign Drug of Abuse Cup Test STAT Dip One Step Drug Test STAT Cup One Step Drug Test STAT Cup II One Step Drug Test STAT Cassette One Step Drug Test First Sign Drug of Abuse Screening Test FIRST SIGN DRUG OF One Step Fentanyl Drug of Abuse Test (10 ng/mL) Pregnancy Test First Sign Drug of Abuse MDMA Dip Card Test First Sign Drug of Abuse MDMA Cup Test First Sign Drug of Abuse EDDP Cup Test First Sign Drug of Abuse Nortriptyline Cup Test First Sign Drug of Abuse Nortriptyline Dip Card Test First Sign Drug of Abuse EDDP Dip Card Test FSH OTC Hemosure Accu-Reader A100 Fluorescence Immunoassay Accu Reader First Sign Drug of Abuse Dip Card Test First Sign Drug of Abuse Cup Test LH Urine Test Strip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2007-11-07
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2007-11-07
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2007-11-07
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2007-11-07
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2007-11-07
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2007-11-07
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2017-04-20
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2017-04-20
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2017-04-20
PVE	Test, Methadone, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3620	2022-05-18
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2005-08-31
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2005-08-31
DKE	Reagents, Test, Tetrahydrocannabinol	Clinical Toxicology	Class 2	862.3870	2005-08-31
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2005-08-31
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2005-08-31
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2005-08-31
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2005-08-31
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3610	2022-05-18
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3100	2022-05-18
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3650	2022-05-18
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2013-11-25
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2017-04-20
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2017-04-20
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2017-04-20
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2014-12-18
OOX	Automated Occult Blood Analyzer	Hematology	Class 2	864.6550	2025-01-13
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	Class 1	862.2560	2021-12-15
PUZ	Test, Benzodiazepine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3170	2022-05-18
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2017-04-20
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2017-04-20
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2017-04-20
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2014-04-02

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

W.H.P.M. Bioresearch & Technology 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
K153050	Co-Innovation Biotech Co., Ltd.	Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard	2016-04-26
K151478	Guangzhou Wondfo Biotech Co., Ltd.	Wondfo CR3 Keyless Split Sample Cup	2015-07-01
K150179	Guangzhou Wondfo Biotech Co., Ltd.	CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids	2015-02-25
K112310	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO METHADONE URINE TEST,OPIATE TEST	2011-09-08
K093175	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO ONE STEP BUPRENORPHINE URINE TEST, OXYCODONE URINE TEST, PROPOXPHENE URINE TEST, MULTIPLE DRUG OF ABUSE URINE TES	2010-08-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2013	Alere San Diego, Inc.	2	Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine.
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 3005345870. Last updated year: 2026. Please use registration number 3005345870 when referencing this establishment in official correspondence.