Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006948883

FEI Number

3006948883

Entity Name

BD Rapid Diagnostics (Suzhou) Co. Ltd.

City/State/Country

China (Jiangsu) Pilot Free Trade Zone Suzhou Area, CN

Establishment Address

No. 9 Ruipu Road, Suzhou Industrial Park, China (Jiangsu) Pilot Free Trade Zone Suzhou Area 215126, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Becton Dickinson and Company (Owner Number: 9922032)

Owner / Operator Contact Address

One Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152870

PMA Number

N/A

All Registered Proprietary Names

BD Veritor System For Rapid Detection of RSV - CLIA waived kit BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B BD Veritor SARS-CoV-2 & Flu A+B Control Swab Set BD Veritor System For Rapid Detection of Flu A+B CLIA-waived kit BD Veritor System For Rapid Detection of Flu A+B Laboratory kit BD Veritor System for Rapid Detection of Flu A+B CLIA-waived kit BD Veritor System For Rapid Detection of Flu A+B CLIA-waived kit BD Veritor System For Rapid Detection of Flu A+B Laboratory kit BD Veritor System For Rapid Detection of Flu A+B Laboratory kit BD Veritor System For Rapid Detection of Flu A+B CLIA-waived kit BD Veritor System For Rapid Detection of Flu A+B CLIA-waived kit BD Veritor System For Rapid Detection of Flu A+B Laboratory kit BD Veritor System Group A Strep Control Swab set BD Veritor System RSV Control Swab Set BD Veritor System Flu A+B Control Swab Set BD Veritor SARS-CoV-2 Control Swab Set BD Veritor System For Rapid Detection of Flu A+B CLIA-waived kit BD Veritor System for Rapid Detection of Flu A+B CLIA-waived kit BD Veritor System For Rapid Detection of Flu A+B CLIA-waived kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GQG	Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Microbiology	Class 1	866.3480	2013-11-25
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown	Class N	N/A	2021-03-30
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2013-11-25
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2013-11-25
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2025-12-11
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2013-11-25
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2016-11-01
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2016-11-01
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2011-11-18
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2016-11-01
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2012-09-20
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-12-12
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2018-06-04
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2025-12-11
PSZ	Devices Detecting Influenza A, B, And C Virus Antigens	Microbiology	Class 2	866.3328	2016-11-01

Official Correspondent

No official correspondent registered.

US Agent Details

Jeffrey Zinza Business: BECTON DICKINSON AND COMPANY Email: jeffrey.zinza@bd.com Phone: (858) 2093953

Related Public Records

Same Entity

Becton Dickinson and Company

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9680577	BECTON DICKINSON GMBH	HEIDELBERG Baden-Wurttemberg, DE
3003916417	BECTON DICKINSON IND. CIRURGICAS LTDA.	CURITIBA Parana, BR
3036495171	BD Biosciences San Diego	San Diego, CA, US
3015292643	BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES	San Diego, CA, US
3010141591	BD Kiestra B.V.	Drachten Fryslan, NL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17
K143376	Siemens Healthcare Diagnostics, Inc.	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	2014-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006948883. Last updated year: 2026. Please use registration number 3006948883 when referencing this establishment in official correspondence.