Zybio Inc.
Registered establishment in Chongqing, China. 2 device types.
Zybio Inc. is a manufacturer holding a current FDA establishment registration. The registration covers Clinical Sample Concentrator, Analyzer, Chemistry (Photometric, Discrete), For Clinical Use. Its earliest product listing with the FDA dates from 2021.
Registration
| Registered name | ZYBIO INC. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3017098905 |
| FEI number | 3017098905 |
| Establishment type | Manufacturer |
Location
| City | Chongqing |
|---|---|
| Province | Chongqing |
| Address | No. 45, Shilin Avenue, Tiaodeng Town, Dadukou District |
| Postal code | 400082 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | Class 1 | EXC200 Chemistry Analyzer | 2024 | 16 |
| Clinical Sample Concentrator | Class 1 | Nucleic Acid Isolation System; Nucleic Acid Extraction Kit (Magnetic Bead Method) | 2021 | 27 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2008 |
|---|---|
| Employees | 2000+ global (600+ master’s degree, 70+ doctors) |
| Main products | Chemistry analyzers, Hematology systems, POCT devices, Molecular testing systems, Immunoassay reagents |
| Certifications | National high-tech enterprise, National enterprise technology center, National post-doctoral research workstation, National IP advantage enterprise |
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.
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