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QIAGEN, GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30040136033004013603QIAGEN, GMBH1N2026-01-01QIAGEN STRASSE 1 HILDEN North Rhine-Westphalia DE 40724

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
232491442151423P210002therascreen PDGFRA RGQ PCR KitOWD2023-06-29
232491181731988P190026therascreen BRAF V600E RGQ PCR KitOWD2020-04-15
232491053292907P190001therascreen PIK3CA RGQ PCR KitOWD2019-05-24
232492035528987P180043therascreen FGFR RGQ RT-PCR KitOWD2019-04-12
232491368142275P130027ARTUS CMV RGQ MDX KITPAB2014-06-02
232491252717155P110030THERASCREEN KRAS RGQ PCR KITOWD2012-07-06
232491523930335K254194QIAstat-Dx BCID GPF Plus AMR PanelPAM2026-08-06
232491138581841K242256QIAstat-Dx Meningitis/Encephalitis (ME) PanelPLO2024-10-29
232491077012902K233100QIAstat-Dx® Respiratory Panel PlusQOF2024-05-10
232491487315723K220062QIAstat-Dx Gastrointestinal Panel 2PCH2024-05-31
232491441515820K183597QIAstat-Dx Respiratory PanelOCC2019-05-18
232491628516407K133936ARTUS C. DIFFICILE QS-RGQ MDX KITOZN2014-04-04
232491443667778K113319ROTOR-GENE Q MDXOOI2012-02-06
232491009080800DEN160028ipsogen JAK2 RGQ PCR KitPSU2017-03-27
232492003556591
232491003924174
232491136129476
232491164307361
232491175917695
232491262076891
232491521846788
232491553502827
232491563072527
232491583000718

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OWD 22020-04-15
PAM12026-08-06
PLO12024-10-29
PCH12024-05-31
QOF12024-05-10
OWD12019-05-24
OCC12019-05-18
PSU12017-03-27
PAB12014-06-02
OZN12014-04-04
OOI12012-02-06

PMN#