PREANALYTIX GMBH

FDA Device Registration & Listing · HOMBRECHTIKON Zurich, CH · Registration 3005202328

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005202328
FEI Number
3005202328
Entity Name
PREANALYTIX GMBH
City/State/Country
HOMBRECHTIKON Zurich, CH
Establishment Address
Garstligweg 8, HOMBRECHTIKON Zurich CH-8634, CH
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
PreAnalytiX GMBH (Owner Number: 9073981)
Owner / Operator Contact Address
1 Becton Drive, Franklin Lakes, NJ 07417, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231469
PMA Number
N/A

All Registered Proprietary Names

PAXgene(R) Blood DNA Tube

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PJE Blood/Plasma Collection Device For Dna Testing Clinical Chemistry Class 2 862.1675 2023-07-10

Official Correspondent

No official correspondent registered.

US Agent Details

Nathan Carrington Business: BECTON DICKINSON AND COMPANY Email: nate.carrington@bd.com Phone: (317) 6455190

Related Public Records

Same Entity

PreAnalytiX GMBH
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005202328. Last updated year: 2026. Please use registration number 3005202328 when referencing this establishment in official correspondence.
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