FDA Registration
Active
🇺🇸 United States
Rapid Diagnostic Tests
Reg #: 3030648160
·
FEI: 3030648160
·
Expires 2025
Products
11
Proprietary Names
1
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- ASSURE TECH LLC
- Registration Number
- 3030648160
- FEI Number
- 3030648160
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1521 Concord Pike Suite 201
- City
- Wilmington
- State
- DE
- ZIP
- 19803
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180349
Owner / Operator
- Firm Name
- Assure Tech LLC
- Operator Number
- 10090182
- Address
- 1521 Concord Pike Suite 201
- City
- Wilmington
- State
- DE
- Postal Code
- 19803
- Country
- US
- Correspondent
- Allen Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2024-02-26 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2024-02-26 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2024-02-26 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2024-02-26 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2024-02-26 |
| Test, Phencyclidine (Pcp), Over The Counter | NGM | Class U | Unknown | No | 2024-02-26 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2024-02-26 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2024-02-26 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2024-02-26 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2024-02-26 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2024-02-26 |
Proprietary Names
Rapid Diagnostic Tests
Establishment Types
Repack or Relabel Medical Device