Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010141591

FEI Number

3010141591

Entity Name

BD Kiestra B.V.

City/State/Country

Drachten Fryslan, NL

Establishment Address

Marconilaan 6, Drachten Fryslan 9207 JC, NL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Becton Dickinson and Company (Owner Number: 9922032)

Owner / Operator Contact Address

One Becton Drive, Franklin Lakes, NJ 07417, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BD Kiestra IdentifA BD Kiestra Methicillin Resistant Staphylococcus aureus (MRSA) Application BD Kiestra IdentifA BD Kiestra InoqulA Magnetic Beads BD Kiestra Isolate Suspension Cuvette Array

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QQV	Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry	Microbiology	Class 2	866.3378	2021-11-11
QBN	Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	Microbiology	Class 2	866.3378	2021-11-11
QQY	Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms	Microbiology	Class 2	866.2190	2023-06-14
QQV	Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry	Microbiology	Class 2	866.3378	2023-09-01
QBN	Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	Microbiology	Class 2	866.3378	2023-09-01
LIB	Device, General Purpose, Microbiology, Diagnostic	Microbiology	Class 1	866.2660	2005-11-04

Official Correspondent

No official correspondent registered.

US Agent Details

Jeffrey Zinza Business: BECTON DICKINSON AND COMPANY Email: jeffrey.zinza@bd.com Phone: (858) 2093953

Related Public Records

Same Entity

Becton Dickinson and Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9680577	BECTON DICKINSON GMBH	HEIDELBERG Baden-Wurttemberg, DE
3003916417	BECTON DICKINSON IND. CIRURGICAS LTDA.	CURITIBA Parana, BR
3036495171	BD Biosciences San Diego	San Diego, CA, US
3015292643	BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES	San Diego, CA, US
9614033	BECTON DICKINSON DE MEXICO	CUAUTITLAN, IZCALLI Queretaro, MX

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.

Similar Registrations

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9615754	BIOMERIEUX SA	LA BALME LES GROTTES Isere, FR
1950204	BIOMERIEUX, INC.	HAZELWOOD, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010141591. Last updated year: 2026. Please use registration number 3010141591 when referencing this establishment in official correspondence.