ASURAGEN, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30034365133003436513ASURAGEN, INC.1N2026-01-012150 WOODWARD ST Suite 100 AUSTIN TX US 78744

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
600951527559368K113420RNARETAINOZF2012-03-16
600951480471866DEN190023AmplideX Fragile X Dx & Carrier Screen KitOYV2020-02-21
600951907746135DEN160003Quantidex qPCR BCR-ABL IS KitOYX2016-07-22
600951334264396
600952024362115
600951131764645
600951526381379
600951553078623
600951833373616
600952011574066

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OYV12020-02-21
OYX12016-07-22
OZF12012-03-16

PMN#

GUDID#