FDA Registration
Active
🇺🇸 United States
ALTA CLIAlyzer Automatic Chemiluminescence Analyzer (REF# CLIA-1)
Reg #: 2032682
·
FEI: 3003952975
·
Expires 2025
Products
1
Proprietary Names
8
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 |
|---|---|---|---|---|---|
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2018-12-11 |
Proprietary Names
ALTA CLIAlyzer Automatic Chemiluminescence Analyzer (REF# CLIA-1)
ALTA Rapid Test Reader (REF# RTR-1)
ALTA Microplate Washer (REF# ADX-120)
RaFIA II Immunofluorescence Analyzer (REF# FIA-102)
RaFIA Immunofluorescence Analyzer (REF# FIA-100)
RaFIA II Semi-automated Immunofluorescence Analyzer (REF# FIA-103)
RaFIA Immunofluorescence Incubator (REF# FIA-101)
ALTA ELISA Reader (REF# ADX-110)
Establishment Types
Manufacture Medical Device