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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

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04053228039402QIAstat-Dx® Respiratory Panel Plus - IVD kit containing 6 tests1-800-426-8157xx@xx.xx
04053228040576EZ2 Connect MDx - The EZ2 Connect MDx is a compact benchtop instrument for automated isolation of nucleic acids from up to 24 samples in parallel, using sealed prefilled cartridgesThe EZ2 Connect MDx system is designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. The EZ2 Connect MDx is intended to be used only in combination with QIAGEN kits indicated for use with the EZ2 Connect MDx instrument for the applications described in the kit handbooks. The EZ2 Connect MDx system is intended for use by professional operators, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ2 Connect MDx system.800-362-7737techservice-na@qiagen.com
04053228043249QIAstat-Dx® Gastrointestinal Panel 2 - IVD kit containing 6 tests800-426-8157xx@xx.xx
14053228039409QIAstat-Dx® Respiratory Panel Plus - V11-800-426-8157xx@xx.xx

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
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
232491138581841
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
PCH12024-05-31
QOF12024-05-10
OWD12019-05-24
OCC12019-05-18
PSU12017-03-27
PAB12014-06-02
OZN12014-04-04
OOI12012-02-06

PMA#

PMN#

GUDID#

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