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
- [email protected]
- Phone
- 310 8060719
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Radioimmunoassay, Tricyclic Antidepressant Drugs | LFG | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2019-04-17 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Test, Morphine, Over The Counter | NGI | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2019-04-17 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Thin Layer Chromatography, Morphine | DNK | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Thin Layer Chromatography, Methamphetamine | DJC | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2019-04-17 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2019-04-17 |
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