FDA Registration
Active
🇺🇸 United States
COVI-Go SARS-CoV-2 Ag Self-Test
Reg #: 3016676574
·
FEI: 3016676574
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- MOLOGIC INC
- Registration Number
- 3016676574
- FEI Number
- 3016676574
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 83 Pineland Dr, Gray Hall Suite 202
- City
- New Gloucester
- State
- ME
- ZIP
- 04260
- Country
- US
Owner / Operator
- Firm Name
- Mologic Inc
- Operator Number
- 10087743
- Address
- 83 Pineland Dr, Gray Hall Suite 202
- City
- New Gloucester
- State
- ME
- Postal Code
- 04260
- Country
- US
- Correspondent
- Andrew Wheeler
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2023-04-03 |
Proprietary Names
COVI-Go SARS-CoV-2 Ag Self-Test
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device