Xiamen Zeesan Biotech Co., Ltd.
Registered establishment in Xiamen, Fujian, China. 6 device types.
Xiamen Zeesan Biotech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Research Use Only/Pathology, Clinical Sample Concentrator and 4 other device types. Its earliest product listing with the FDA dates from 2020.
Registration
| Registered name | XIAMEN ZEESAN BIOTECH CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013540184 |
| FEI number | 3013540184 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Xiamen |
|---|---|
| Province | Fujian |
| Address | No. 884-1 and 884-2 Lianting Road, (Xiang An) Industrial Area, Torch High-Tech Zone |
| Postal code | 361101 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Sterile | Class 1 | Disposable Sampling Swab, Type A-01, Type A-02, Type A-03, Type A-04, Type A-05 | 2020 | 100 |
| Clinical Sample Concentrator | Class 1 | ZEESAN, Lab-Aid 960 Virus RNA Extraction Kit, 96 Tests/Kit, ZEESAN, Lab-Aid Virus RNA Extraction Kit, 48 Tests/Kit, ZEESAN, Virus RNA Extraction Kit, 100 Tests/Kit, ZEESAN, Nucleic Acid Extraction System, Lab-Aid 960, ZEESAN, Nucleic Acid Extraction System, Lab-Aid 824s, ZEESAN, Total RNA Blood Kit (Lab-Aid), 48 Tests/Kit and 12 more | 2020 | 27 |
| Container, Specimen, Non-Sterile | Class 1 | ZEESAN, Saliva Collection Kit, model SAL-2000L, ZEESAN, Virus RNA Collection Kit, model V-2000, ZEESAN, Saliva RNA Sample Collection Kit, model R-2000, ZEESAN, Virus RNA Collection Kit, model V01-1000, V01-2000, V01-3000, ZEESAN, Saliva RNA Sample Collection Kit, model R01-2000 | 2020 | 115 |
| Instrumentation For Clinical Multiplex Test Systems | Class 2 | Real-Time PCR System, model: SLAN-96S, SLAN-96P, SLAN-48P, ZEESAN, Sanity 2 System, model: Sanity2 | 2021 | 9 |
| Reagents, 2019-Novel Coronavirus Nucleic Acid | Class N | ZEESAN, SARS-CoV-2 Test Kit (Real-time PCR), 48 Test/Kit | 2021 | 5 |
| Research Use Only/Pathology | Class N | ZEESAN, PML-RAR? V Detection Kit, Model 20 Tests/Kit, ZEESAN, PML RAR? L Detection Kit, Model 20 Tests/Kit, ZEESAN, MTB/MDR Test Kit (Sanity 2), Model 24 Tests/Kit, ZEESAN, Respiratory Pathogen Panel (RPP17D), Model 48 Tests/Kit, ZEESAN, Leukemia Fusion Genes (Q30) Screening Kit, ZEESAN, BCR-ABL1 p190 Detection Kit, Model 20 Tests/Kit and 52 more | 2021 | 1 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Employees | 501-1000 |
| Factory area | 1700 sq meters |
| Main products | Molecular diagnostic kits, Nucleic acid extraction kits, Real-time PCR systems, Sanity 2.0 system |
| Certifications | ISO 9001, ISO 13485, CE-IVDD, CE-IVDR, NMPA Medical Device |
| Export markets | Asia, Europe, Americas |
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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