Preanalytix G M B H

FDA Filings

This page includes the latest FDA filings for Preanalytix G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005202328
• FEI Number: 3005202328
• Name: Kay Taylor
• Owner & Operator: PREANALYTIX GMBH
• Contact Address: FELDBACHSTRASSE --; HOMBRECHTIKON CH-NOTA CH-8634 CH
• US Agent:
  • Kay Taylor
  • 201 8476800
  • Kay.Kuckewich-Taylor@bd.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1 Becton Drive ; Franklin Lakes, NJ 07417 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 04053727611659 PreAnalytiX GmbH	PAXgene® Blood DNA Tube 761165	2023-11-09
GUDID 54053727621653 PreAnalytiX GmbH	PAXgene® Blood RNA Tube 762165	2018-07-06
GUDID 54053727611654 PreAnalytiX GmbH	PAXgene® Blood DNA Tube 761165	2018-03-29
PMN K142821 | PJE Kay Taylor [PREANALYTIX GMBH]	PAXgene(R) Blood DNA Tube	2015-11-04
PMN K142821 PREANALYTIX GMBH	PAXgene Blood DNA Tube	2015-09-09
PMN K082150 PREANALYTIX GMBH	MODIFICATION TO PAXGENE BLOOD RNA SYSTEM	2009-02-04
PMN DEN050003 | NTW Kay Taylor [PREANALYTIX GMBH]	PAXgene Blood RNA System	2007-12-05
De Novo DEN050003 PREANALYTIX GMBH	PAXGENE BLOOD RNA SYSTEM	2005-04-18