Shanghai ZJ BIO-Tech Co., Ltd.
Registered establishment in Shanghai, China. 3 device types.
Shanghai ZJ BIO-Tech Co., Ltd. is a private-label distributor holding a current FDA establishment registration. The registration covers Reagents, Specific, Analyte, Clinical Sample Concentrator and 1 other device type. Its earliest product listing with the FDA dates from 2015.
Registration
| Registered name | SHANGHAI ZJ BIO-TECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007143373 |
| FEI number | 3007143373 |
| Establishment type | Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 26 Building, 588 XINJUNHUAN ROAD, Pujiang High-tech Park. |
| Postal code | 201114 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Clinical Sample Concentrator | Class 1 | Automated Nucleic Acid Extraction Instrument (EX3600), Automated Nucleic Acid Extraction Instrument (EX9600), Specimen Pretreatment system (QGMate), Automated Nucleic Acid Extraction Instrument (EX3600 Plus), Specimen Distribution System (AutraMate Plus), Automated Workstation for Sample Preparation (Autra9600 Super) and 4 more | 2021 | 27 |
| Instrumentation For Clinical Multiplex Test Systems | Class 2 | Automated Workstation for Nucleic Acid Extraction and PCR Test (AutraMic mini 4800 Plus), Automated Workstation for Nucleic Acid Extraction and PCR Test (AutraMic mini3200), Automated Workstation for Nucleic Acid Extraction and PCR Test (AutraMic mini4800), Liferiver Intelligent Molecular Mobile Mini-Lab, Automated Workstation for Nucleic Acid Extraction & PCR Setup (Autra4800 Plus), Automated Workstation for Nucleic Acid Extraction & PCR Setup (Autra9600 Plus) and 1 more | 2021 | 9 |
| Reagents, Specific, Analyte | Class 1 | Viral RNA Extraction Kit (for Auto-Extraction), Viral RNA Isolation Kit (Preloaded for Auto-Extraction), Viral RNA Isolation Kit (for Auto-Extraction), Liferiver@ AutoEX36 A Extraction Kit | 2015 | 6 |
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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