FDA.reportPublic FDA data

DIASORIN INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21825952182595DIASORIN INC.1Y2026-01-011951 Northwestern Ave Stillwater MN US 55082

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
08056771600811ANAFLUOR™ - 1662651-439-9710info@diasorin.com
08056771600828ANAFLUOR™ - 1660651-439-9710info@diasorin.com
08056771600835ANAFLUOR ™ - 1624651-439-9710info@diasorin.com
08056771600842ANAFLUOR™ - 6624651-439-9710info@diasorin.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
208632031832717P970025PRO-TRAC II TACROLIMUS ELISA KITMLM1999-04-27
208631154785615K951639COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)DAE1995-10-13
208631410572710K940271INCSTAR ACTH IRMACKG1994-08-02
208631805955769K892526SPQ TM TEST SYSTEM II FOR CRPDCK1989-05-09
208631653695814K884298SPQ(TM) TEST SYSTEM FOR MICROALBUMINJZJ1988-11-02
208631832668476K884297SPQ(TM) TEST SYSTEM FOR PREALBUMINJZJ1988-11-02
208631246560884K870862SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN ALMSJ1987-03-24
208631224277754K870564SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN BMSJ1987-03-24
208631707199597K861167IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TESTCZP1986-04-25
208631550988451K822397ANA HEP-2 FLUORO-KITDHN1982-09-21
208631161632615K770057NDNA IMMUNOPATH FLUORO-KITDHN1977-04-05
208631328300570K213936LIAISON MeMed BV, LIAISON MeMed BV Control SetQPS2022-07-14
208631282188018K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusNXO2022-07-26
208631980493973K202574LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody PlusLSR2021-02-18
208631556185290K202573LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody PlusLSR2021-02-18
208631718953468K193532LIAISON Anti-HAV AssayLOL2020-03-02
208631102782292K193051LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control SetLSR2020-01-29
208631391016729K192586LIAISON® FolateCGN2020-05-06
208631702557567K192064LIAISON Vitamin B12CDD2019-10-02
208631626212768K192046LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control SetQFO2019-10-28
208631255469938K182698LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. DeviceNXO2018-12-26
208631867528427K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetLYR2018-08-31
208631989187459K161522LIAISON EBV IgM Serum Control SetJJX2016-06-30
208631843300187K161139LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetLYR2016-07-22
208631478643684K150879LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersCEW2015-06-22
208631390964079K141463LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERSMRG2014-12-10
208631096573380K132515LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERSCEW2013-11-08
208632003261686K130321LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERSCJM2013-04-09
208631652003391K122793LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SETCDZ2013-01-25
208631173354803K112725LIAISON 25 OH VITAMIN D TOTAL ASSAYMRG2012-01-20
208631971910078K090104LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603JJX2009-09-09
208631390219823K081687LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGGMYF2008-11-10
208631932376065K081685LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGGMXJ2008-11-18
208631575319401K071480LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602MRG2007-10-01
208631187984510K062473LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871LSR2007-04-12
208631796036534K061247DIASORIN LIAISON TREPONEMA ASSAYLIP2006-07-31
208631129601187K011958CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KITDCN2001-12-04
208631136655348
208631359621722
208631397947731
208631473221331
208631628798923
208631727362201
208631736188029
208632045646043
208631045112315
208631059055552
208631132845419
208631205340820
208631226592488
208631304236437
208631336532726
208631358746476
208631409182786
208631410361514
208631415813938
208631596161468
208631658312498
208631701772719
208631737223313
208631761343219
208631791460869
208631801195120
208631828606535
208631854203955
208631878287208
208631882729186
208631905312439
208631926995636
208631971549117
208631975407402
208632007733717
208632008781998

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LSR42021-02-18
MRG32014-12-10
NXO22022-07-26
LYR22018-08-31
JJX22016-06-30
CEW22015-06-22
JZJ21988-11-02
MSJ21987-03-24
DHN21982-09-21
QPS12022-07-14
CGN12020-05-06
LOL12020-03-02
QFO12019-10-28
CDD12019-10-02
CJM12013-04-09
CDZ12013-01-25
MXJ12008-11-18
MYF12008-11-10
LIP12006-07-31
DCN12001-12-04
DAE11995-10-13
CKG11994-08-02
DCK11989-05-09
CZP11986-04-25

PMA#

PMN#

GUDID#

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