FDA.reportPublic FDA data

DIASYS DIAGNOSTIC SYSTEMS GMBH

Matched from indexed company URL: DiaSys Diagnostic Systems GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30066446203006644620DIASYS DIAGNOSTIC SYSTEMS GMBH1N2026-01-01ALTE STRASSE 9 Holzheim Rhineland-Palatinate DE D-65558

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
262851534845525K242294DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level ControlsPTF2025-05-09
262851207504675
262851295169435
262851664711825
262851732217885

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PTF12025-05-09

PMN#

GUDID#