Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012073813

FEI Number

3012073813

Entity Name

Hangzhou AllTest Biotech Co.,Ltd

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

No. 550, Yinhai Street, Hangzhou Economic & Technological Development Area, Hangzhou Zhejiang 310018, CN

Establishment Type(s)

Manufacture Medical Device

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Methamphetamine(MET) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Drink Check Test Atida Multiplex Drug of Abuse Cup Test Atida Multiplex Drug of Abuse Dip Card Test Citest Multi Drug Test Panel AimScreen Multi-Drug Test Panel CHOSEN Multi-Drug Urine Rapid Test Panel Rx ACRO Multi-Drug Urine Test Panel AllTest Multi-Drug Rapid Test Panel AllTest Multi-Drug Rapid Test Cup Rx One Step 7 Drug Multi-Panel Urine Test Citest Multi Drug Rapid Test Panel BEB Multi-Drug Rapid Test Cup Exploro Highly Sensitive 5-PANEL URINE DRUG TEST Discover Multi-Drug Rapid Test Panel SpecCheck Multi-Drug Rapid Test Cup ACRO Multi-Drug Urine Test Cup PRECISION DX Multi-Panel Drug Test Card CHOSEN Multi-Drug Urine Rapid Test Panel Citest Multi Drug Test Cup PRECISION DX Multi-Drug Rapid Urine Test Cup CHOSEN Multi-Drug Urine Rapid Test Cup Rx AllTest Multi-Drug Rapid Test Cup Mobilab Multi-Drug Rapid Test CUP AllTest Multi-Drug Rapid Test Panel Rx Mobilab Multi-Drug Rapid Test Panel Atida Multiplex Drug of Abuse Cup Test Rx Identify Health Multi-Drug Rapid Test Dip CHOSEN Multi-Drug Urine Rapid Test Cup Citest Multi Drug Rapid Test Cup ACRO Multi-Drug Test Cup ACRO Multi-Drug Test Panel Atida Multiplex Drug of Abuse Dip Card Test Rx SpecCheck Multi-Drug Rapid Test Panel Identify Diagnostics Multi-Drug Rapid Test Panel Propoxyphene(PPX) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT THYROCHEK Thyroid Test Rapid TSH Cassette (Whole Blood) CLIAwaived Inc. Thyroid Test Rapid TSH Cassette (Whole Blood) Morphine(MOP) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Certum Adulteration Dipstick Adulteration Dipstick 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 AllTest Strep A 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 DeviceRDTDfor 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 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 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 Cocaine(COC) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Methadone(MTD) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Atida Viral Transport Medium Citest Viral Transport Medium ACRO Viral Transport Medium AllTest Viral Transport Medium Barbiturate(BAR) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Opiates(OPI) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT Marijuana(THC) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT 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 Ovulation (LH) Rapid Test Cassette Ovulation (LH) Rapid Test Dipstick Digital LH Ovulation Test Strip Ovulation (LH) Rapid Test Midstream BERKELEY HEALTH Ovulation LH Test QuickScreen At Home Digital Ovulation Test 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 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) Benzodiazepines(BZO) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT 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 CHOSEN Multi-Drug Urine Test Cup Atida Multiplex Drug of Abuse Rapid Urine Cup Test ACRO Multi-Drug Screen Cup Identify Health Multi-Drug Rapid Urine Test Cup Citest Multi-Drug Urine Test Cup AllTest Multi-Drug Rapid Urine Test Cup Identify Diagnostics Multi-Drug Urine Test Cup CHOSEN Multi-Drug Rapid Urine Test Cup Atida Multiplex Drug of Abuse Urine Cup Test ACRO Multi-Drug Screen Cup for Home use DrugTect Multi-Drug Rapid Urine Test Cup Identify Health Multi-Drug Urine Test Cup CLIAwaived,Inc. Complete Drug Test Cup CDTC Labb Multi Drug Urine Test Cup Labb Multi Drug Rapid Urine Test Cup DrugTect Multi-Drug Urine Test Cup ONESCREEN PLUS Multi-Panel Drug Test Cup AllTest Multi-Drug Urine Test Cup Identify Diagnostics Multi-Drug Rapid Urine Test Cup Citest Multi-Drug Urine Cup BERKELEY HEALTH Vaginal pH Test Citest Multi-Drug Urine Cup Rapid Response Drug Screen Cup Atida Multiplex Drug of Abuse Urine Cup Test AllTest Multi-Drug Rapid Urine Test Cup CLIAwaived,Inc. Rapid Test Cup RTC + Fentanyl Premier Bio-Cup X ACRO Multi-Drug Rapid Test Cup AllTest Multi-Drug Urine Test Cup DrugTect Multi-Drug Rapid Urine Test Cup Discover Plus Multi-Drug Rapid Urine Test Cup Citest Multi-Drug Urine Test Cup ACRO Multi-Drug Rapid Urine Test Cup Atida Multiplex Drug of Abuse Rapid Urine Cup Test QuickScreen Multi Drug Screening Test With "Timer" AMPHETAMINE(AMP) Rapid Test, EMPLOYMENT AND INSURANCE TESTING, EXEMPT 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 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PVD	Test, Methamphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3610	2017-11-02
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2023-12-15
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2023-12-15
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2023-12-15
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2023-12-15
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2023-12-15
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2023-12-15
LAF	Gas Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2023-12-15
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2023-12-15
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2023-12-15
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2023-12-15
LFG	Radioimmunoassay, Tricyclic Antidepressant Drugs	Clinical Toxicology	Class 2	862.3910	2023-12-15
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2023-12-15
DJC	Thin Layer Chromatography, Methamphetamine	Clinical Toxicology	Class 2	862.3610	2023-12-15
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2023-12-15
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2023-12-15
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2023-12-15
NGI	Test, Morphine, Over The Counter	Clinical Toxicology	Class 2	862.3640	2023-12-15
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2023-12-15
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2023-12-15
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2023-12-15
DNK	Thin Layer Chromatography, Morphine	Clinical Toxicology	Class 2	862.3640	2023-12-15
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2023-12-15
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2023-12-15
PVI	Test, Propoxyphene, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3700	2017-11-02
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2019-07-30
PVG	Test, Morphine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3640	2017-11-02
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	2024-04-10
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2026-05-11
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
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	2024-08-19
PVA	Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3250	2017-11-02
PVE	Test, Methadone, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3620	2017-11-02
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2025-04-16
PUY	Test, Barbiturate, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3150	2017-11-02
PVH	Test, Opiates, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3650	2017-10-30
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3870	2017-11-02
LCX	Kit, Test, Pregnancy, Hcg, Over The Counter	Clinical Chemistry	Class 2	862.1155	2025-07-21
NGE	Test, Luteinizing Hormone (Lh), Over The Counter	Clinical Chemistry	Class 1	862.1485	2024-05-27
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2023-08-02
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
PUZ	Test, Benzodiazepine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3170	2017-11-02
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
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2025-04-16
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2025-04-16
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2025-04-16
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2025-04-16
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2025-04-16
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2025-04-16
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2025-04-16
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2025-04-16
QBF	Test, Propoxyphene, Over The Counter	Clinical Toxicology	Class 2	862.3700	2025-04-16
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2025-04-16
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2025-04-16
LNW	Paper, Obstetric Ph	Clinical Chemistry	Class 1	862.1550	2026-04-10
NFV	Test, Benzodiazepine, Over The Counter	Clinical Toxicology	Class 2	862.3170	2024-06-26
PTH	Test, Barbiturate, Over The Counter	Clinical Toxicology	Class 2	862.3150	2024-06-26
NFY	Test, Cocaine And Cocaine Metabolites, Over The Counter	Clinical Toxicology	Class 2	862.3250	2024-06-26
PTG	Test, Methadone, Over The Counter	Clinical Toxicology	Class 2	862.3620	2024-06-26
NGM	Test, Phencyclidine (Pcp), Over The Counter	Unknown	Class U	N/A	2024-06-26
NFT	Test, Amphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3100	2024-06-26
NGG	Test, Methamphetamine, Over The Counter	Clinical Toxicology	Class 2	862.3610	2024-06-26
QAW	Test, Tricyclic Antidepressants, Over The Counter	Clinical Toxicology	Class 2	862.3910	2024-06-26
NFW	Test, Cannabinoid, Over The Counter	Clinical Toxicology	Class 2	862.3870	2024-06-26
NGL	Test, Opiates, Over The Counter	Clinical Toxicology	Class 2	862.3650	2024-06-26
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
PUX	Test, Amphetamine, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3100	2017-11-02
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
NGA	Test, Follicle Stimulating Hormone (Fsh), Over The Counter	Clinical Chemistry	Class 1	862.1300	2017-07-28

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
3027519599	Hangzhou AllTest Biotech Co.,Ltd	Hangzhou Zhejiang, CN
3043127647	Hangzhou AllTest Biotech Co.,Ltd	Hangzhou Zhejiang, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970265	Drial Consultants, Inc.	ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST	1997-04-08
K051161	Quest Diagnostics, Inc.	QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)	2005-11-22
K122904	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;	2012-11-15
K121987	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO AMPHETAMINE URINE TEST WONDFO BARBITURATES URINE TEST WONDFO BENZODIAZEPINES URINE TEST	2012-08-01
K111560	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST	2011-07-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0007-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0008-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0009-2010	Biosite Inc	2	Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
Z-0010-2010	Biosite Inc	2	Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. 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 3012073813. Last updated year: 2026. Please use registration number 3012073813 when referencing this establishment in official correspondence.