FDA Registration
Active
🇨🇳 China
rapid diagnostic test
Reg #: 3009585529
·
FEI: 3009585529
·
Expires 2025
Products
11
Proprietary Names
8
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- ASSURE TECH. (HANGZHOU) CO., LTD.
- Registration Number
- 3009585529
- FEI Number
- 3009585529
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 4, No. 1418-50, Moganshan Road, Gongshu District
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K181768
Owner / Operator
- Firm Name
- Assure Tech. (Hangzhou) Co., Ltd.
- Operator Number
- 10040710
- Address
- Building 4, No. 1418-50, Moganshan Road, Gongshu District
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 310011
- Country
- CN
- Correspondent
- Shisheng Ling
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2018-09-02 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2018-09-02 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2018-09-02 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2018-09-02 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2018-09-02 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2018-09-02 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2018-09-02 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2018-09-02 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2018-09-02 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2018-09-02 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2018-09-02 |
Proprietary Names
rapid diagnostic test
VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT / TEST DIP CARD MULTI DRUG
Rapid Response Drug Screening Cup
Rapid Response Drug Screening Panel
Premier Bio-Panel Dip Tests
Rapid Diagnostic Tests
VIVITAR laboratories THE SOLUTION HOME RAPID TEST KIT /MULTI TEST CUP
Premier Bio-Cup Tests
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device