Genobio Pharmaceutical Co., Ltd.
Registered establishment in Tianjin, China. 1 device type.
Genobio Pharmaceutical Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Antisera, Latex Agglutination, Cryptococcus Neoformans. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | GENOBIO PHARMACEUTICAL CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014655875 |
| FEI number | 3014655875 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 天津喜诺生物医药有限公司 |
|---|---|
| Unified social credit code | 911201160937317765 |
| Source | NMPA UDI database |
Location
| City | Tianjin |
|---|---|
| Province | Tianjin |
| Address | 2-1,2,3-101,No.2 Zone, Binlv Industrial Park,Binhai Tourism Area,Binhai New Area |
| Postal code | 300480 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Antisera, Latex Agglutination, Cryptococcus Neoformans | Class 2 | Cryptococcal Capsular Polysaccharide Detection K-Set (Lateral Flow Assay) | 2020 | 1 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Main products | SARS-CoV-2 Antigen Rapid Test, SARS-CoV-2 Molecular Detection Kit, Fungus (1-3)-β-D-Glucan Test, Aspergillus Galactomannan ELISA Detection Kit, Full-Automatic Chemiluminescence Immunoassay System |
| Certifications | ISO 13485, ISO 9001, MDSAP, KGMP, CE, NMPA, FSC, Health Canada, FDA |
| Export markets | 70+ countries worldwide |
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.