Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017358793

FEI Number

3017358793

Entity Name

JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD.

City/State/Country

Taizhou Jiangsu, CN

Establishment Address

No. 837, Yaocheng Avenue, 225300 Taizhou City, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA, Taizhou Jiangsu 225300, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bioperfectus (Owner Number: 10075899)

Owner / Operator Contact Address

3rd and 4th floors of Building A(G19), 4th floor of Building F(G14), Ground floor of Building G20, Shuaiyu Vil, 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

Real-time PCR System COVID-19 Coronavirus Real Time PCR Kit

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	2022-06-17
QJR	Reagents, 2019-Novel Coronavirus Nucleic Acid	Unknown	Class N	N/A	2020-07-22

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Bioperfectus

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
Z-0004-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0005-2022	Abbott Molecular, Inc.	N	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Z-0006-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Z-0007-2022	Abbott Molecular, Inc.	N	Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

Similar Registrations

Registration Number	Establishment Name	Location
3005370583	KORVIS LLC (DBA Ascential Medical & Life Sciences)	Corvallis, OR, US
3005269352	Invetech Pty Ltd	Mount Waverley Victoria, AU
3002773840	BioFire Diagnostics, LLC	Salt Lake City, UT, US
3007361513	EUROIMMUN Medizinische Labordiagnostika AG	Dassow Mecklenburg-Western Pomerania, DE
2243471	ROCHE MOLECULAR SYSTEMS, INC.	Branchburg, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017358793. Last updated year: 2026. Please use registration number 3017358793 when referencing this establishment in official correspondence.