FDA Registration
Active
🇳🇱 Netherlands
BD Kiestra B.V.
Reg #: 3010141591
·
FEI: 3010141591
·
Expires 2026
Products
9
Proprietary Names
41
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- BD Kiestra B.V.
- Registration Number
- 3010141591
- FEI Number
- 3010141591
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Marconilaan 6
- City
- Drachten Fryslan
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K191964
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 |
|---|---|---|---|---|---|
| Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry | QQV | Class 2 | Microbiology | No | 2021-11-11 |
| Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates | QBN | Class 2 | Microbiology | No | 2021-11-11 |
| Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms | QQY | Class 2 | Microbiology | No | 2023-06-14 |
| Device, General Purpose, Microbiology, Diagnostic | LIB | Class 1 | Microbiology | No | 2005-11-04 |
| Automated Colony Counter | KZB | Class 1 | Microbiology | No | 2018-02-20 |
| Device, Microtiter Diluting/Dispensing | JTC | Class 1 | Microbiology | No | 2011-04-21 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2004-12-14 |
| Bath, Incubators/Water, All | JTQ | Class 1 | Microbiology | No | 2004-11-23 |
| Calculator/Data Processing Module, For Clinical Use | JQP | Class 1 | Clinical Chemistry | No | 2008-09-16 |
Proprietary Names
BD Kiestra IdentifA
BD Kiestra Methicillin Resistant Staphylococcus aureus (MRSA) Application
BD Kiestra InoqulA Magnetic Beads
BD Kiestra Isolate Suspension Cuvette Array
BD Kiestra Urine Culture Application Powered by BD Synapsys Informatics Solution
BD Kiestra InoqulA+
BD Kiestra InoqulA+ TLA
BD Kiestra InoqulA
BD Kiestra InoqulA Track
BD Kiestra Slide Processing Module
BD Kiestra InoqulA Track with SPM
BD Kiestra InoqulA with SPM
BD Kiestra Slides
BD BBL Sensi-Disc 8-Place Self-Tamping Dispenser
BD BBL Sensi-Disc 6-Place Self-Tamping Dispenser
BD BBL Sensi-Disc 12-Place Self-Tamping Dispenser
BD Kiestra IdentifA WCA Connection
BD Kiestra IdentifA Manual Infeed
BD BBL Sensi-Disc Single Disc Dispenser
BD Kiestra IdentifA TLA Connection
BD Macro-Vue Card Test Rotator
BD Dispenstirs
BD Disposable Inoculating Needles, Violet
BD Calibrated Disposable Inoculating Loops, Green
BD Calibrated Disposable Inoculating Loops, Blue
BD Kiestra ReadA Compact
BD Kiestra ReadA
BD EpiCenter Data Management System
BD Kiestra Corner
BD Kiestra U-Turn
BD Kiestra Destacker
BD Kiestra Regular Base
BD Kiestra Standard Connector
BD Kiestra Main Base Light
BD Kiestra T-junction
BD Kiestra Main Base
BD Kiestra Stacker
BD Kiestra Frame
BD Kiestra Straight
BD Kiestra ErgonomicA Connector R
BD Kiestra ErgonomicA Connector L
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device