FDA Registration
Active
🇺🇸 United States
Rapid Diagnostic Tests
Reg #: 3030648160
·
FEI: 3030648160
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
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
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, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2024-03-07 |
Proprietary Names
Rapid Diagnostic Tests
HealCare LH Ovulation Rapid Test
OvaMate Fertility Predictor kit (With OvaMate APP)
Establishment Types
Repack or Relabel Medical Device