What does BD Rapid Diagnostics (Suzhou) Co., Ltd. manufacture?

Registered with the FDA for 6 device types.

Is BD Rapid Diagnostics (Suzhou) Co., Ltd. still registered with the FDA?

Yes. The registration is current and expires 2026.

BD Rapid Diagnostics (Suzhou) Co., Ltd. → Supplier → Allomedo

BD Rapid Diagnostics (Suzhou) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Covid-19 Multi-Analyte Antigen Device, Antigens, All Groups, Streptococcus Spp. and 4 other device types. Its earliest product listing with the FDA dates from 2011.

Registration

FDA registration record for BD Rapid Diagnostics (Suzhou) Co., Ltd.
Registered name	BD Rapid Diagnostics (Suzhou) Co. Ltd.
Status	Registered
Registration expires	2026
Registration number	3006948883
FEI number	3006948883
Establishment type	Manufacturer

Chinese Registration

Chinese company register details for BD Rapid Diagnostics (Suzhou) Co., Ltd.
Chinese legal name	碧迪快速诊断产品（苏州）有限公司
Source	Qichacha company register

Location

Address of BD Rapid Diagnostics (Suzhou) Co., Ltd.
City	China (Jiangsu) Pilot Free Trade Zone Suzhou Area
Address	No. 9 Ruipu Road
Postal code	215126
Country	China

Group

BD Rapid Diagnostics (Suzhou) Co., Ltd. is one of 2 plants registered under Becton Dickinson and Company.

Other plants under Becton Dickinson and Company
Plant	City	Device types
Becton Dickinson Medical Devices Co., Ltd. Suzhou	Suzhou	2

What It Makes

Device types BD Rapid Diagnostics (Suzhou) Co., Ltd. is registered to make
Device type	Class	Listed under the names	Listed since	Chinese makers
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus	Class 1	BD Veritor™ System For Rapid Detection of RSV – Laboratory kit, BD Veritor™ System For Rapid Detection of RSV – CLIA waived kit	2012	4
Antigens, All Groups, Streptococcus Spp.	Class 1	BD Veritor™ System for Rapid Detection of Group A Strep CLIA-Waived Kit	2013	6
Covid-19 Multi-Analyte Antigen Device	Class N	BD Veritor™ SARS-CoV-2 & Flu A+B Control Swab Set, BD Veritor™ System for Rapid Detection of SARS-CoV-2 & Flu A+B	2021	7
Devices Detecting Influenza A, B, And C Virus Antigens	Class 2	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	2011	2
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings	Class 2	BD Veritor™ System for Rapid Detection of SARS-CoV-2	2025	3
Single (Specified) Analyte Controls (Assayed And Unassayed)	Class 1	BD Veritor™ System RSV Control Swab Set, BD Veritor™ System Group A Strep Control Swab set, BD Veritor™ System Flu A+B Control Swab Set, BD Veritor™ SARS-CoV-2 Control Swab Set	2017	12

Clearances

No clearance names BD Rapid Diagnostics (Suzhou) Co., Ltd. as applicant. 22 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.

510(k) clearances naming BD Rapid Diagnostics (Suzhou) Co., Ltd. or its listings
Clearance	Decision date	Product code	Route	Held by
K243872	2025-06-16	QVF	Dual Track	Becton, Dickinson AND Company
K232434	2023-12-05	PSZ	Traditional	BD Medical
K223016	2023-01-27	PSZ	Traditional	BD Medical
K180438	2018-03-20	PSZ	Special	BD Medical
K160164	2016-02-25	PSZ	Special	Becton, Dickinson & Co.
K160161	2016-02-24	PSZ	Special	Becton, Dickinson & Co.
K152870	2015-10-27	PSZ	Special	Becton, Dickinson AND Company
K152874	2015-10-27	PSZ	Special	Becton, Dickinson AND Company
K151291	2015-06-10	PSZ	Special	Becton, Dickinson AND Company
K151301	2015-06-08	PSZ	Special	Becton, Dickinson AND Company
K133140	2013-11-15	GQG	Special	Becton, Dickinson & Co.
K133138	2013-11-13	PSZ	Special	Becton, Dickinson & Co.
K132456	2013-11-07	GQG	Traditional	Becton, Dickinson AND Company
K132693	2013-10-02	PSZ	Special	Becton, Dickinson AND Company
K132692	2013-09-23	PSZ	Special	Becton, Dickinson AND Company
K132256	2013-08-07	PSZ	Special	Becton, Dickinson AND Company
K132259	2013-08-07	PSZ	Special	Becton, Dickinson AND Company
K122718	2013-02-06	GTY	Traditional	Becton, Dickinson AND Company
K121633	2012-09-18	GQG	Traditional	Becton, Dickinson AND Company
K121797	2012-09-07	PSZ	Traditional	Becton, Dickinson AND Company
K120049	2012-03-23	PSZ	Traditional	Becton, Dickinson AND Company
K112277	2011-10-28	PSZ	Traditional	Becton, Dickinson AND Company

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.

The manufacturer named here can complete this record.

BD Rapid Diagnostics (Suzhou) Co., Ltd.