FDA Registration
Active
🇺🇸 United States
BD Vaginal Panel on BD COR System
Reg #: 1119779
·
FEI: 1119779
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- BECTON, DICKINSON & CO.
- Registration Number
- 1119779
- FEI Number
- 1119779
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 7 LOVETON CIR.
- City
- SPARKS
- State
- MD
- ZIP
- 21152
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223653
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Trichomonas Vaginalis Nucleic Acid Amplification Test System | OUY | Class 2 | Immunology | No | 2023-04-11 |
| Real Time Nucleic Acid Amplification System | OOI | Class 2 | Clinical Chemistry | No | 2023-04-11 |
| Instrumentation For Clinical Multiplex Test Systems | NSU | Class 2 | Clinical Chemistry | No | 2023-04-11 |
| Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System | PQA | Class 2 | Microbiology | No | 2023-04-11 |
Proprietary Names
BD Vaginal Panel on BD COR System
BD Vaginal Panel
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device