FDA Registration
Active
🇨🇳 China
BD Rapid Diagnostics (Suzhou) Co. Ltd.
Reg #: 3006948883
·
FEI: 3006948883
·
Expires 2026
Products
6
Proprietary Names
13
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- BD Rapid Diagnostics (Suzhou) Co. Ltd.
- Registration Number
- 3006948883
- FEI Number
- 3006948883
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 9 Ruipu Road, Suzhou Industrial Park
- City
- China (Jiangsu) Pilot Free Trade Zone Suzhou Area
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K132456
Owner / Operator
- Firm Name
- Becton Dickinson and Company
- Operator Number
- 9922032
- Address
- One Becton Drive
- City
- Franklin Lakes
- State
- NJ
- Postal Code
- 07417
- Country
- US
US Agent
- Business Name
- BECTON DICKINSON AND COMPANY
- Contact Name
- Jeffrey Zinza
- Address
- 7 Loveton Circle
- City
- Sparks
- State
- MD
- ZIP
- 21152
- Country
- US
- [email protected]
- Phone
- 858 2093953
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | GQG | Class 1 | Microbiology | No | 2013-11-25 |
| Covid-19 Multi-Analyte Antigen Device | QMN | Class N | Unknown | No | 2021-03-30 |
| Devices Detecting Influenza A, B, And C Virus Antigens | PSZ | Class 2 | Microbiology | No | 2013-11-25 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2017-12-12 |
| Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | QVF | Class 2 | Microbiology | No | 2025-07-01 |
| Antigens, All Groups, Streptococcus Spp. | GTY | Class 1 | Microbiology | No | 2013-02-26 |
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 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 SARS-CoV-2
BD Veritor System For Rapid Detection of RSV - Laboratory kit
BD Veritor System for Rapid Detection of Group A Strep CLIA-Waived Kit
Establishment Types
Manufacture Medical Device