Geneseeq Medical Device AND Diagnostic Inc.
Registered establishment in Nanjing, Jiangsu, China. 1 device type.
Geneseeq Medical Device AND Diagnostic Inc. is a contract manufacturer holding a current FDA establishment registration. The registration covers Next Generation Sequencing Based Tumor Profiling Test. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | GENESEEQ MEDICAL DEVICE AND DIAGNOSTIC INC. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3043140667 |
| FEI number | 3043140667 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Nanjing |
|---|---|
| Province | Jiangsu |
| Address | 128 Huakang Road |
| Postal code | 210000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Next Generation Sequencing Based Tumor Profiling Test | Class 2 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) | 2025 | 1 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Employees | 1500 |
| Factory area | 400000 |
| Main products | NGS precision oncology, diagnostic kits, tumor sequencing |
| Certifications | CAP, CLIA, ISO15189, ISO13485 |
| Export markets | 20+ countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.