FDA Registration
Active
🇨🇳 China
GENESEEQ MEDICAL DEVICE AND DIAGNOSTIC INC.
Reg #: 3043140667
·
FEI: 3043140667
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GENESEEQ MEDICAL DEVICE AND DIAGNOSTIC INC.
- Registration Number
- 3043140667
- FEI Number
- 3043140667
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 128 Huakang Road, Jiangbei New Area
- City
- Nanjing Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Geneseeq Medical Device and Diagnostic Inc.
- Operator Number
- 10094752
- Address
- 128 Huakang Road, Jiangbei New Area
- City
- Nanjing
- State
- Jiangsu
- Postal Code
- 210000
- Country
- CN
- Correspondent
- Yedan Chen
US Agent
- Business Name
- QA/RA CONSULTING GROUP, INC.
- Contact Name
- Scott Bednar
- Address
- 3335 Tuscarawas Rd
- City
- Beaver
- State
- PA
- ZIP
- 15009
- Country
- US
- [email protected]
- Phone
- 412 4188066
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Next Generation Sequencing Based Tumor Profiling Test | PZM | Class 2 | Pathology | No | 2025-12-20 |
Proprietary Names
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)