FDA.reportPublic FDA data

QIAGEN Manchester Ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30051180203009391812QIAGEN Manchester Ltd1N2026-01-01CityLabs 2.0 200 Hathersage Road Manchester Lancashire GB M13 0BH

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
717761400773553P110030THERASCREEN KRAS RGQ PCR KITOWD2012-07-06
717761500907833K113319ROTOR-GENE Q MDXOOI2012-02-06
717761745290127

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OWD 12012-07-06
OOI12012-02-06

PMA#