FDA Registration Active 🇨🇳 China

One Step THC Rapid Urine Test Strips

Reg #: 3012073813 · FEI: 3012073813 · Expires 2025
Products
23
Proprietary Names
38
Establishment Types
1
Classifications
23

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
K182738

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
Phone
310 8060719

Products

Device Name Product Code
Test, Tricyclic Antidepressants, Over The Counter QAW
Enzyme Immunoassay, Barbiturate DIS
Radioimmunoassay, Tricyclic Antidepressant Drugs LFG
Test, Phencyclidine (Pcp), Over The Counter NGM
Enzyme Immunoassay, Opiates DJG
Test, Morphine, Over The Counter NGI
Enzyme Immunoassay, Phencyclidine LCM
Test, Barbiturate, Over The Counter PTH
Thin Layer Chromatography, Morphine DNK
Enzyme Immunoassay, Amphetamine DKZ
Test, Amphetamine, Over The Counter NFT
Test, Opiates, Over The Counter NGL
Test, Benzodiazepine, Over The Counter NFV
Test, Methamphetamine, Over The Counter NGG
Thin Layer Chromatography, Methamphetamine DJC
Test, Cannabinoid, Over The Counter NFW
Test, Methadone, Over The Counter PTG
Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
Enzyme Immunoassay, Cannabinoids LDJ
Gas Chromatography, Methamphetamine LAF
Enzyme Immunoassay, Benzodiazepine JXM
Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
Enzyme Immunoassay, Methadone DJR

Proprietary Names

One Step THC Rapid Urine Test Strips Discover Multi-Drug Rapid Test Cup (Urine) Rapid Response Drug Screening Cup- OTC (Urine) Rapid Response Drug Screening Panel- OTC (Urine) Atida Single Drug Drug of Abuse Strip Test L-Cup Rapid Test w/Adulteration (Urine) Citest Multiplex DOA Test Cup (Urine) Multi-Drug Rapid Test Panel With or without Adulteration (Urine) Atida Single Drug Drug of Abuse Strip Test Rx Citest Multiplex DOA Test Panel (Urine) CHOSEN Single Drug Urine Rapid Test Dipstick Multi-Drug Rapid Test Cup With or without Adulteration (Urine) CHOSEN Single Drug Urine Rapid Test Dipstick Rx ACRO Single Drug Urine Test Strip VeriCheck Drug Test Cup (Urine) Citest Multiplex DOA Home Test Panel (Urine) Rapid Response Drug Screening Cup w/wo Adulteration (Urine) L-Cup Home Rapid Test (Urine) Clarity Diagnostics Multi-Drug Home Rapid Test Cup (Urine) Rapid Response Drug Screening Strip w/wo Adulteration (Urine) Citest Single Drug Rapid Test Strip Citest Single Drug Test Strip AllTest Single and Multi-Drug Rapid Test Panel With Adulteration AllTest Single and Multi-Drug Home Rapid Test Cup AllTest Single Drug Rapid Test Dipstick AllTest Single and Multi-Drug Rapid Test Panel AllTest Single and Multi-Drug Rapid Test Cup With Adulteration AllTest Single Drug Home Rapid Test Dipstick AllTest Single and Multi-Drug Rapid Test Cup AllTest Single and Multi-Drug Home Rapid Test Panel L-Cup Drug Test (Urine) Rapid Response Drug Screening Panel w/wo Adulteration (Urine) Citest Multiplex DOA Home Test Cup (Urine) Rapid Response Drug Screening Test Strip- OTC (Urine) Clarity Diagnostics Multi-Drug Home Rapid Test Panel (Urine) Test Yourself At Home Home Rapid Test Cup VeriCheck Drug Test Dip (Urine) ACRO Single Drug Test Strip

Establishment Types

Manufacture Medical Device