FDA Registration
Active
🇨🇳 China
Automated Workstation for Nucleic Acid Extraction and PCR Test (AutraMic mini4800)
Reg #: 3007143373
·
FEI: 3007143373
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SHANGHAI ZJ BIO-TECH CO., LTD.
- Registration Number
- 3007143373
- FEI Number
- 3007143373
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 26 Building, 588 XINJUNHUAN ROAD, Pujiang High-tech Park.
- City
- SHANGHAI
- Country
- CN
Owner / Operator
- Firm Name
- Shanghai ZJ Bio-Tech Co., Ltd.
- Operator Number
- 10048869
- Address
- 588 XINJUNHUAN ROAD, BUILDING 26
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201114
- Country
- CN
- Correspondent
- Huihui Yang
US Agent
- Business Name
- LIFERIVER BIO-TECH (UNITED STATES) CORP.
- Contact Name
- WALTER ZHANG
- Address
- 505 Coast Blvd. South, Suite 401 La Jolla, CALIFORNIA, 92037, UNITED STATES
- City
- San Diego
- State
- CA
- ZIP
- 92121
- Country
- US
- [email protected]
- Phone
- 858 3526520
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2021-06-04 |
Proprietary Names
Automated Workstation for Nucleic Acid Extraction and PCR Test (AutraMic mini4800)
Automated Workstation for Nucleic Acid Extraction and PCR Test (AutraMic mini 4800 Plus)
Automated Workstation for Nucleic Acid Extraction and PCR Test (AutraMic mini3200)
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)
Life9600 Real-Time PCR System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device