FDA Registration
Active
🇺🇸 United States
BD COR (PX/MX) 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
- K210585
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 |
|---|---|---|---|---|---|
| Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | QEP | Class 2 | Microbiology | No | 2022-05-19 |
| Dna-Reagents, Neisseria | LSL | Class 2 | Microbiology | No | 2022-05-19 |
| Trichomonas Vaginalis Nucleic Acid Amplification Test System | OUY | Class 2 | Immunology | No | 2022-05-19 |
| Dna Probe, Nucleic Acid Amplification, Chlamydia | MKZ | Class 1 | Microbiology | No | 2022-05-19 |
Proprietary Names
BD COR (PX/MX) System
BD CTGCTV2
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device