Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007143373

FEI Number

3007143373

Entity Name

SHANGHAI ZJ BIO-TECH CO., LTD.

City/State/Country

SHANGHAI, CN

Establishment Address

26 Building, 588 XINJUNHUAN ROAD, Pujiang High-tech Park., SHANGHAI 201114, CN

Establishment Type(s)

Foreign Private Label Distributor,Manufacture Medical Device

Owner / Operator

Shanghai ZJ Bio-Tech Co., Ltd. (Owner Number: 10048869)

Owner / Operator Contact Address

588 XINJUNHUAN ROAD, BUILDING 26, Shanghai, CN-SH 201114, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

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 & PCR Setup (Autra4800 Plus) Automated Workstation for Nucleic Acid Extraction and PCR Test (AutraMic mini4800) Liferiver Intelligent Molecular Mobile Mini-Lab Life9600 Real-Time PCR System Automated Workstation for Nucleic Acid Extraction & PCR Setup (Autra9600 Plus) Viral RNA Isolation Kit (Preloaded for Auto-Extraction) Liferiver@ AutoEX36 A Extraction Kit Viral RNA Extraction Kit (for Auto-Extraction) Viral RNA Isolation Kit (for Auto-Extraction) Automated Nucleic Acid Extraction Instrument (EX3600) Automated Nucleic Acid Extraction Instrument (EX9600) Specimen Pretreatment system (QGMate) Automated Nucleic Acid Extraction Instrument (EX9600 Plus) Automated Nucleic Acid Extraction Instrument (Autra9600) Specimen Distribution System (AutraMate Plus) Specimen Distribution System (AutraMate Super) Automated Nucleic Acid Extraction Instrument (EX3600 Plus) Automated Workstation for Sample Preparation (Autra9600 Super) Automated Nucleic Acid Extraction Instrument (EX1600 Plus)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2021-06-04
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2015-03-12
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2021-02-20

Official Correspondent

Huihui Yang

US Agent Details

WALTER ZHANG Business: LIFERIVER BIO-TECH (UNITED STATES) CORP. Email: usa@liferiverbiotech.com Phone: (858) 3526520

Related Public Records

Same Entity

Shanghai ZJ Bio-Tech Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2018	Hologic, Inc	2	Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007143373. Last updated year: 2026. Please use registration number 3007143373 when referencing this establishment in official correspondence.