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Abbott Molecular Distribution Center

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30198379623019837962Abbott Molecular Distribution Center1Y2026-01-011015 West Devon Itasca IL US 60143

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2948481111492234P230003Alinity m HR HPVMAQ2023-11-01
2948481587924514P210022Alinity m CMVPAB2022-05-05
2948481805965732P190025Alinity m HCVMZP2020-03-23
2948482040089977P160044ABBOTT REALTIME CMVPAB2017-05-18
2948481607306097P150041VYSIS CLL FISH PROBE KITPNK2016-04-11
2948481913746976P110012VYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALKOWE2011-08-26
2948481436424352P030052UROVYSION BLADDER CANCER KIT2005-01-24
2948481941339185K241573Alinity m Resp-4-PlexQOF2025-02-14
2948481198000596K222379Alinity m STI AssayQEP2023-03-03
2948481200101773K202977Alinity m STI AssayQEP2022-04-29
2948481349259325K140354ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NGLSL2014-05-09
2948481194652361K131508VYSIS D7S486/CEP 7 FISH PROBE KITPFG2013-09-13
2948481461115465K080739ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KITMKZ2008-07-10
2948481623294705K010288ANEUVYSION MULITICOLOR DNA PROBE KITOYU2001-04-13
2948481611379840DEN130010VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)PDO2013-07-29
2948481261225755BP060002
2948481000247602
2948481065945321
2948481077458425
2948481091700756
2948481120778147
2948481164659802
2948481250210257
2948481428855341
2948481431575021
2948481476742266
2948481547656267
2948481626575308
2948481751965150
2948481839834389
2948481857320796
2948481971168791
2948482006216459
2948482026792790

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QEP22023-03-03
QOF12025-02-14
PAB 12022-05-05
PAB12017-05-18
PNK12016-04-11
LSL12014-05-09
PFG12013-09-13
PDO12013-07-29
OWE12011-08-26
MKZ12008-07-10
OYU12001-04-13