Hangzhou AllTest Biotech Co.,Ltd

FDA Device Registration & Listing · Hangzhou Zhejiang, CN · Registration 3027519599

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3027519599
FEI Number
3027519599
Entity Name
Hangzhou AllTest Biotech Co.,Ltd
City/State/Country
Hangzhou Zhejiang, CN
Establishment Address
#383, Qiaoxin Road, Xiasha Street, Qiantang District, Hangzhou Zhejiang 310018,, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Hangzhou AllTest Biotech Co.,Ltd (Owner Number: 10050156)
Owner / Operator Contact Address
#383, Qiaoxin Road, Xiasha Street, Qiantang District, Hangzhou, CN-ZJ 310018, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Benzodiazepines(BZO) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Marijuana(THC) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT FSH Rapid Test Cassette FSH Rapid Test Midstream FSH Rapid Test Dipstick QuickScreen At Home FSH/Menopause Rapid Test (Urine) One Step FSH Urine midstream Test BERKELEY HEALTH Menopause FSH Test One Step FSH Urine test strip Identify Diagnostics Multi-Drug Rapid Urine Test Dip Identify Diagnostics Multi-Drug Urine Test Dip Identify Health Multi-Drug Rapid Urine Test Dip AllTest Multi-Drug Urine Test Panel Citest Multi-Drug Urine Test Panel Citest Multi-Drug Urine Panel Atida Multiplex Drug of Abuse Rapid Urine Dip Card Test CHOSEN Multi-Drug Urine Test Panel Premier Bio-Dip X Atida Multiplex Drug of Abuse Urine Dip Card Test CHOSEN Multi-Drug Rapid Urine Test Panel AllTest Multi-Drug Rapid Urine Test Panel DrugTect Multi-Drug Urine Test Panel Rapid Response Drug Screen Panel Identify Health Multi-Drug Urine Test Dip ACRO Multi-Drug Rapid Urine Test Panel DrugTect Multi-Drug Rapid Urine Test Panel ONESCREEN PLUS Multi-Drug Rapid Urine Test Panel ACRO Multi-Drug Rapid Test Panel PRECISION PLUS Multi-Panel Rapid Urine Test Card Discover Multi-Panel Rapid Urine Test Card Propoxyphene(PPX) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Methamphetamine(MET) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Drink Check Test AMPHETAMINE(AMP) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT WorkCHEK Breath Alcohol Test, For employment and insurance use Morphine(MOP) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT HCG OTC Rapid Urine Test Midstream HCG Pregnancy Rapid Test Midstream One Step Self-Test Pregnancy Test Midstream ALLTEST hCG Pregnancy Rapid Test Citest Pregnancy Home Test Test Yourself @ Home (TY@H) One-Step Pregnancy Test Atida Pregnancy Test Identify Health Digital Early Pregnancy Test Shinetell Plus Digital Early Pregnancy Test Citest Digital Early Pregnancy Home Test QuickScreen At Home Digital Early Pregnancy Test Atida Digital Early Pregnancy Test 2San Digital Early Pregnancy Test Optilyte Plus Digital Early Pregnancy Rapid Test Opiates(OPI) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Optilyte Digital Pregnancy Rapid Test Identify Health Digital Pregnancy Test Citest Digital Pregnancy Home Test CHOSEN Digital hCG Pregnancy Urine Rapid Test Midstream Atida Digital Pregnancy Test Rapid Response Digital Pregnancy Test Discover Digital Pregnancy Test Shinetell™ Digital Pregnancy Test VeriCheck Drug Test Cup (Urine) One Step Ecstasy (MDMA) Urine Test Strip ACRO Single Drug Test Strip One Step Cocaine (COC) Urine Test Strip Clarity Diagnostics Multi-Drug Home Rapid Test Cup (Urine) Citest Single Drug Rapid Test Strip AllTest Single and Multi-Drug Rapid Test Panel With Adulteration AllTest Single and Multi-Drug Home Rapid Test Cup AllTest Single Drug Home Rapid Test Dipstick AllTest Single and Multi-Drug Home Rapid Test Panel AllTest Single Drug Rapid Test Dipstick AllTest Single and Multi-Drug Rapid Test Cup AllTest Single and Multi-Drug Rapid Test Panel AllTest Single and Multi-Drug Rapid Test Cup With Adulteration One Step THC Rapid Urine Test Strips CHOSEN Single Drug Urine Rapid Test Dipstick Multi-Drug Rapid Test Cup With or without Adulteration (Urine) Rapid Response Drug Screening Test Strip- OTC (Urine) Citest Single Drug Test Strip Citest Multiplex DOA Home Test Panel (Urine) ACRO Single Drug Urine Test Strip Citest Multiplex DOA Home Test Cup (Urine) Rapid Response Drug Screening Panel w/wo Adulteration (Urine) One Step Methamphetamine (MET) Urine Test Strip Rapid Response Drug Screening Cup w/wo Adulteration (Urine) Citest Multiplex DOA Test Panel (Urine) VeriCheck Drug Test Dip (Urine) Test Yourself At Home Home Rapid Test Cup Rapid Response Drug Screening Panel- OTC (Urine) Atida Single Drug Drug of Abuse Strip Test Rx One Step Amphetamine (AMP) Urine Test Strip CHOSEN Single Drug Urine Rapid Test Dipstick Rx One Step Benzodiazepine (BZO) Urine Test Strip Atida Single Drug Drug of Abuse Strip Test One Step Morphine (MOP) Urine Test Strip Rapid Response Drug Screening Cup- OTC (Urine) L-Cup Home Rapid Test (Urine) L-Cup Rapid Test w/Adulteration (Urine) Citest Multiplex DOA Test Cup (Urine) Multi-Drug Rapid Test Panel With or without Adulteration (Urine) Rapid Response Drug Screening Strip w/wo Adulteration (Urine) L-Cup Drug Test (Urine) Discover Multi-Drug Rapid Test Cup (Urine) Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine) Atida Viral Transport Medium Citest Viral Transport Medium ACRO Viral Transport Medium AllTest Viral Transport Medium CHOSEN hCG Early Pregnancy Urine Rapid Test Midstream ACRO Early Pregnancy Rapid Test ACESO Early Pregnancy Test Atida Early Pregnancy Test 2San Early Result Pregnancy Test Berkeley health hCG Early Pregnancy Rapid Test Citest Early Pregnancy Home Test ALLTEST hCG Early Pregnancy Rapid Test getTested Early Pregnancy Test One Step hCG Early Rapid Pregnancy Test Midstream Identify Health hCG Early Pregnancy Rapid Test Discover Fentanyl Rapid Test Cassette Atida Fentanyl Drug of Abuse Test Identify Health Fentanyl Urine Test Cassette McKesson Consult Fentanyl Urine Test Cassette Atida Fentanyl Test One Step Fentanyl Urine Test Cassette CHOSEN Fentanyl Rapid Urine Test Cassette Rapid Response Fentanyl Test Cassette CHOSEN Fentanyl Urine Rapid Test Cassette Mobilab Fentanyl Urine Test Cassette GenaCheck Fentanyl Urine Test Cassette Citest Fentanyl Home Test ACRO Fentanyl Urine Test Cassette DrugTect Fentanyl Urine Cassette RapiSure Fentanyl Urine Test Cassette ACRO Fentanyl Urine Test AllTest FentanyI Urine Test Cassette (Home Test) Rapid Response At-Home Fentanyl Test Cassette GenaCheck Fentanyl Urine Home-Use Test Cassette CLIAwaived, Inc. Rapid Drug Test Device“RDTD”for Fentanyl in Urine AimScreen Fentanyl Test 2SAN Fentanyl Urine Test Cassette RapiSure FYL Fentanyl Urine Test Cassette Identify Diagnostics Fentanyl Urine Cassette Citest Fentanyl Rapid Test BERKELEY HEALTH Vaginal pH Test AllTest Strep A Rapid Test AllTest Urinary Tract Infection Test Atida Urinary Tract Infection Test Urinary Tract Infection Test Identify Health Urinary Tract Infection Test Rapid Response Urinary Tract infection Screen Strips Berkeley health Urinary Tract Infections Rapid Test 2San UTI Test Mobilab Urinary Tract Infection Test Vivoo At-Home UTI Test Strips Citest Urinary Tract Infection Test ACRO Urinary Tract Infection Rapid Test QuickScreen At Home Urinary Tract Infection Test Methadone(MTD) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Alltest Pregnancy Rapid Combo Test Cassette Citest hCG Pregnancy Combo Rapid Test Atida hCG Pregnancy Rapid Combo Test ACRO hCG Pregnancy Combo Test CLARITY hCG Combo Cassette Medline hCG Combo Pregnancy Test Cassette CHOSEN hCG Pregnancy Combo Rapid Test Cassette Rx Identify Health Pregnancy Rapid Combo Test Cassette Certum Adulteration Dipstick Adulteration Dipstick QUICKSTICK ONE STEP PREGNANCY TEST Define-Test de Embarazo HCG Cocaine(COC) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT AllTest Fentanyl Rapid Test (Urine) Discover Fentanyl Rapid Test Cassette Rx Fentanyl Test (Urine) Rapid Response Fentanyl Test Cassette (Urine) Atida Fentanyl Drug of Abuse Test Rx CHOSEN Fentanyl Urine Rapid Test Cassette Rx QuickScreen Multi Drug Screening Test With "Timer"

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PUZ Test, Benzodiazepine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3170 2017-11-02
PVJ Test, Cannabinoid, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3870 2017-11-02
NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter Clinical Chemistry Class 1 862.1300 2017-07-28
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2024-09-28
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2024-09-28
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2024-09-28
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2024-09-28
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2024-09-28
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2024-09-28
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2024-09-28
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2024-09-28
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2024-09-28
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2024-09-28
PVI Test, Propoxyphene, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3700 2017-11-02
PVD Test, Methamphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3610 2017-11-02
PUX Test, Amphetamine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3100 2017-11-02
DJZ Devices, Breath Trapping, Alcohol Clinical Toxicology Class 1 862.3050 2024-04-12
PVG Test, Morphine, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3640 2017-11-02
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2018-06-11
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2025-07-21
PVH Test, Opiates, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3650 2017-10-30
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2024-08-19
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2019-04-17
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2019-04-17
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2019-04-17
LFG Radioimmunoassay, Tricyclic Antidepressant Drugs Clinical Toxicology Class 2 862.3910 2019-04-17
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2019-04-17
LCM Enzyme Immunoassay, Phencyclidine Unknown Class U N/A 2019-04-17
DNK Thin Layer Chromatography, Morphine Clinical Toxicology Class 2 862.3640 2019-04-17
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2019-04-17
DKZ Enzyme Immunoassay, Amphetamine Clinical Toxicology Class 2 862.3100 2019-04-17
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2019-04-17
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2019-04-17
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2019-04-17
DJC Thin Layer Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2019-04-17
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2019-04-17
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2019-04-17
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2019-04-17
NGI Test, Morphine, Over The Counter Clinical Toxicology Class 2 862.3640 2019-04-17
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2019-04-17
LDJ Enzyme Immunoassay, Cannabinoids Clinical Toxicology Class 2 862.3870 2019-04-17
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2019-04-17
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2019-04-17
DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites Clinical Toxicology Class 2 862.3250 2019-04-17
LAF Gas Chromatography, Methamphetamine Clinical Toxicology Class 2 862.3610 2019-04-17
JSM Culture Media, Non-Propagating Transport Microbiology Class 1 866.2390 2025-04-16
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2024-04-10
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2023-11-02
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2023-11-02
LNW Paper, Obstetric Ph Clinical Chemistry Class 1 862.1550 2026-04-10
GTY Antigens, All Groups, Streptococcus Spp. Microbiology Class 1 866.3740 2026-05-11
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2025-11-21
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2025-11-21
PVE Test, Methadone, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3620 2017-11-02
JHI Visual, Pregnancy Hcg, Prescription Use Clinical Chemistry Class 2 862.1155 2022-02-18
CEN Dye-Indicator, Ph (Urinary, Non-Quantitative) Clinical Chemistry Class 1 862.1550 2017-08-29
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2026-04-02
PVA Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt Clinical Toxicology Class 2 862.3250 2017-11-02
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2023-08-02
DJR Enzyme Immunoassay, Methadone Clinical Toxicology Class 2 862.3620 2019-12-31
DJG Enzyme Immunoassay, Opiates Clinical Toxicology Class 2 862.3650 2019-12-31
DIS Enzyme Immunoassay, Barbiturate Clinical Toxicology Class 2 862.3150 2019-12-31
JXM Enzyme Immunoassay, Benzodiazepine Clinical Toxicology Class 2 862.3170 2019-12-31

Official Correspondent

Rosa Wu

US Agent Details

Joseph Fan Business: ACESO LABORATORIES INC. Email: manuel@acrobiotech.com Phone: (909) 5415085

Related Public Records

Same Entity

Hangzhou AllTest Biotech Co.,Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3043127647 Hangzhou AllTest Biotech Co.,Ltd Hangzhou Zhejiang, CN
3012073813 Hangzhou AllTest Biotech Co.,Ltd Hangzhou Zhejiang, CN

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K241741 Guangzhou Wondfo Biotech Co., Ltd. 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 2024-07-16
K252550 Guangzhou Wondfo Biotech Co., Ltd. SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx 2025-11-18
K202567 Guangzhou Wondfo Biotech Co., Ltd. Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx 2020-09-25
K260065 Guangzhou Wondfo Biotech Co., Ltd. SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx 2026-04-28
K182701 Guangzhou Wondfo Biotech Co., Ltd. Wondfo T-Cup Multi-Drug Urine Test Cup 2018-12-03

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 3027519599. Last updated year: 2026. Please use registration number 3027519599 when referencing this establishment in official correspondence.
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