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QIAGEN

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
11223763003572099QIAGEN1Y2026-01-0119300 Germantown Rd Germantown MD US 20874

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
437712047587540P890064VIRATYPE HUMAN PAPILLOMAVIRUS DNA TYPING KITMAQ1991-03-11
437711585215387P160052PartoSure testQBB2018-04-11
437711090333643P010033QUANTTFERON-TB GOLD AND TB GOLD-IN-THE-TUBENCD2001-11-28
437711469970727K990023HYBRID CAPTURE II CT-ID TESTLSK1999-10-25
437711900312882K981485HYBRID CAPTURE II GC-IDLSL1999-11-29
437711239786911K971586DIGENE CERVICAL BRUSHHHT1997-09-19
437711458732302K081767AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1NQM2009-01-09
437711228555736K030849AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1JJX2004-02-02
437711343585869
437711357461563
437711052540368
437711132246434
437711176367210
437711226323993
437711296755361
437711918680342

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QBB12018-04-11
NQM12009-01-09
JJX12004-02-02
NCD12001-11-28
LSL11999-11-29
LSK11999-10-25
HHT11997-09-19
MAQ11991-03-11

PMA#

44 records. Showing 41-44. Previous

PMN#