FDA Registration
Active
🇺🇸 United States
BIOTEKE USA LLC
Reg #: 3028746593
·
FEI: 3028746593
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- BIOTEKE USA LLC
- Registration Number
- 3028746593
- FEI Number
- 3028746593
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 900 Brickell Key Blvd Suite 2304
- City
- Miami
- State
- FL
- ZIP
- 33131
- Country
- US
Owner / Operator
- Firm Name
- Bioteke USA LLC
- Operator Number
- 10088753
- Address
- 900 Brickell Key Blvd Suite 2304
- City
- Miami
- State
- FL
- Postal Code
- 33131
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2023-10-08 |
Proprietary Names
Bio-Self COVID-19 Antigen Home Test
Establishment Types
Repack or Relabel Medical Device
Remanufacture Medical Device
Reprocess Single-Use Device