PRECISION DX Multi-Drug Rapid Urine Test Cup

Registration Details

Registration Name: Hangzhou AllTest Biotech Co.,Ltd
Registration Number: 3012073813
FEI Number: 3012073813
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: No. 550, Yinhai Street, Hangzhou Economic & Technological Development Area
City: Hangzhou Zhejiang
Country: CN

Regulatory Submissions

510(k) Number: K233019

Owner / Operator

Firm Name: Hangzhou AllTest Biotech Co.,Ltd
Operator Number: 10050156
Address: No. 550, Yinhai Street, Hangzhou Economic & Technological Development Area
City: Hangzhou
State: Zhejiang
Postal Code: 310018
Country: CN
Correspondent: Yanli Wu

US Agent

Business Name: ACESO LABORATORIES INC.
Contact Name: Joseph Fan
Address: 14020 Central Ave, Suite 520
City: Chino
State: CA
ZIP: 91710
Country: US
Email: [email protected]
Phone: 310 8060719

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Enzyme Immunoassay, Cocaine And Cocaine Metabolites	DIO	Class 2	Clinical Toxicology	No	2023-12-15
Test, Methamphetamine, Over The Counter	NGG	Class 2	Clinical Toxicology	No	2023-12-15
Gas Chromatography, Methamphetamine	LAF	Class 2	Clinical Toxicology	No	2023-12-15
Test, Cocaine And Cocaine Metabolites, Over The Counter	NFY	Class 2	Clinical Toxicology	No	2023-12-15
Enzyme Immunoassay, Methadone	DJR	Class 2	Clinical Toxicology	No	2023-12-15
Test, Cannabinoid, Over The Counter	NFW	Class 2	Clinical Toxicology	No	2023-12-15
Test, Opiates, Over The Counter	NGL	Class 2	Clinical Toxicology	No	2023-12-15
Test, Tricyclic Antidepressants, Over The Counter	QAW	Class 2	Clinical Toxicology	No	2023-12-15
Enzyme Immunoassay, Phencyclidine	LCM	Class U	Unknown	No	2023-12-15
Test, Phencyclidine (Pcp), Over The Counter	NGM	Class U	Unknown	No	2023-12-15
Radioimmunoassay, Tricyclic Antidepressant Drugs	LFG	Class 2	Clinical Toxicology	No	2023-12-15
Test, Methadone, Over The Counter	PTG	Class 2	Clinical Toxicology	No	2023-12-15
Enzyme Immunoassay, Amphetamine	DKZ	Class 2	Clinical Toxicology	No	2023-12-15
Enzyme Immunoassay, Cannabinoids	LDJ	Class 2	Clinical Toxicology	No	2023-12-15
Test, Amphetamine, Over The Counter	NFT	Class 2	Clinical Toxicology	No	2023-12-15
Test, Benzodiazepine, Over The Counter	NFV	Class 2	Clinical Toxicology	No	2023-12-15
Thin Layer Chromatography, Methamphetamine	DJC	Class 2	Clinical Toxicology	No	2023-12-15
Enzyme Immunoassay, Barbiturate	DIS	Class 2	Clinical Toxicology	No	2023-12-15
Test, Morphine, Over The Counter	NGI	Class 2	Clinical Toxicology	No	2023-12-15
Enzyme Immunoassay, Opiates	DJG	Class 2	Clinical Toxicology	No	2023-12-15
Enzyme Immunoassay, Benzodiazepine	JXM	Class 2	Clinical Toxicology	No	2023-12-15
Thin Layer Chromatography, Morphine	DNK	Class 2	Clinical Toxicology	No	2023-12-15
Test, Barbiturate, Over The Counter	PTH	Class 2	Clinical Toxicology	No	2023-12-15

Proprietary Names

PRECISION DX Multi-Drug Rapid Urine Test Cup CHOSEN Multi-Drug Urine Rapid Test Cup Rx ACRO Multi-Drug Test Panel ACRO Multi-Drug Urine Test Panel CHOSEN Multi-Drug Urine Rapid Test Panel Atida Multiplex Drug of Abuse Dip Card Test Rx ACRO Multi-Drug Urine Test Cup CHOSEN Multi-Drug Urine Rapid Test Panel Rx Atida Multiplex Drug of Abuse Dip Card Test CHOSEN Multi-Drug Urine Rapid Test Cup AllTest Multi-Drug Rapid Test Cup Rx Exploro Highly Sensitive 5-PANEL URINE DRUG TEST SpecCheck Multi-Drug Rapid Test Panel BEB Multi-Drug Rapid Test Cup Citest Multi Drug Test Panel AllTest Multi-Drug Rapid Test Panel Citest Multi Drug Test Cup Citest Multi Drug Rapid Test Cup Discover Multi-Drug Rapid Test Panel One Step 7 Drug Multi-Panel Urine Test PRECISION DX Multi-Panel Drug Test Card SpecCheck Multi-Drug Rapid Test Cup Atida Multiplex Drug of Abuse Cup Test Rx Atida Multiplex Drug of Abuse Cup Test AllTest Multi-Drug Rapid Test Panel Rx AllTest Multi-Drug Rapid Test Cup Citest Multi Drug Rapid Test Panel ACRO Multi-Drug Test Cup

Establishment Types

Manufacture Medical Device