FDA.reportPublic FDA data

AUTOGENOMICS, INCORPORATED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30054060973005406097AUTOGENOMICS, INCORPORATED1N2026-01-011600 Faraday Avenue Carlsbad CA US 92008

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2354691969516896P230032AvertD and AvertD Buccal Sample Collection KitQZH2023-12-19
2354692065620866K101683INFINITI CYP2C19 ASSAYNTI2010-10-25
2354691767741520K073014INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARINODW2008-01-23
2354691928231998K060564INFINITI SYSTEMNPQ2007-02-07
2354691017884193
2354691190522199
2354691326827501
2354691383834312
2354691573352720
2354691577099203
2354691684716509
2354691820173556
2354691868355152
2354691901599605
2354692072286200
2354691468511301
2354691556006268
2354691773067275
2354691790562477
2354691816208738
2354692028002913

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NTI12010-10-25
ODW12008-01-23
NPQ12007-02-07

PMN#