FDA Registration
Active
🇺🇸 United States
RapidLight CK-MB CLIA Test (REF# L3020)
Reg #: 2032682
·
FEI: 3003952975
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CTK BIOTECH, INC.
- Registration Number
- 2032682
- FEI Number
- 3003952975
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 13855 Stowe Dr
- City
- Poway
- State
- CA
- ZIP
- 92064
- Country
- US
Owner / Operator
- Firm Name
- CTK BIOTECH, INC.
- Operator Number
- 9051784
- Address
- 13855 Stowe Dr., --
- City
- Poway
- State
- CA
- Postal Code
- 92064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Atp And Creatine Kinase (Enzymatic), Creatine | JLB | Class 1 | Clinical Chemistry | No | 2020-08-20 |
Proprietary Names
RapidLight CK-MB CLIA Test (REF# L3020)
RaFIA CK-MB FIA Test (REF# F3020)
Establishment Types
Manufacture Device in the United States for Export Only