FDA.reportPublic FDA data

PREANALYTIX GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30052023283005202328PREANALYTIX GMBH1N2026-01-01Garstligweg 8 HOMBRECHTIKON Zurich CH CH-8634

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
241501715075887K231469PAXgene® Blood DNA TubePJE2023-06-21
241502051049460K142821PAXgene Blood DNA TubePJE2015-09-09
241501018216636K082150MODIFICATION TO PAXGENE BLOOD RNA SYSTEMNTW2009-02-04
241501575397979DEN050003PAXGENE BLOOD RNA SYSTEMNTW2005-04-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PJE22023-06-21
NTW22009-02-04

PMN#

GUDID#