FDA Registration
Active
🇹🇼 Taiwan
GenXplore q4800 Automated qPCR-based Nucleic Acid Testing System
Reg #: 3003083993
·
FEI: 3003083993
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- CHROMA ATE INC.
- Registration Number
- 3003083993
- FEI Number
- 3003083993
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 68 Huaya 1st Road, Guishan
- City
- Taoyuan
- Country
- TW
Owner / Operator
- Firm Name
- Chroma ATE Inc.
- Operator Number
- 10081652
- Address
- No. 88, Wenmao Rd., Guishan Dist.
- City
- Taoyuan
- State
- TW-NOTA
- Postal Code
- 333001
- Country
- TW
- Correspondent
- Victor Chen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2024-06-04 |
Proprietary Names
GenXplore q4800 Automated qPCR-based Nucleic Acid Testing System
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device