FDA.reportPublic FDA data

DiaSorin Molecular LLC

Matched from indexed company URL: DIASORIN INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20233652023365DiaSorin Molecular LLC1Y2026-01-0111331 Valley View St CYPRESS CA US 90630
21825952182595DIASORIN INC.1Y2026-01-011951 Northwestern Ave Stillwater MN US 55082
96102403002808212DiaSorin Italia S.p.A.1N2026-01-01VIA CRESCENTINO, snc SALUGGIA Vercelli IT 13040
30085760403008576040DiaSorin Italia S.p.A UK Branch1N2026-01-01Central Road Dartford Kent GB DA1 5LR
30124496453012449645DiaSorin Canada Inc.1N2026-01-015075 Whittle Road Suite 210 & 140 Mississauga Ontario CA L4Z 3N1

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
208621055984160P990045DIASORIN ETI-AB-COREK PLUS ASSAY2001-03-30
208621966151722P990044DIASORIN ETI-CORE-IGMK PLUS ASSAY2001-03-30
208622040479560P990043DIASORIN ETI-EBK PLUS ASSAYLOM2001-02-08
208621251343934P990042DIASORIN ETI-AB-AUK PLUS ASSAY2001-03-30
208621823605106P990041DIASORIN ETI-AB-EBK PLUS ASSAY2001-03-30
208621811209533P990038DIASORIN ETI MAK-2 PLUS ASSAYLOM2001-03-30
208621360371867P970055BIOTRIN PARVOVIRUS IGM EIA (V619IMUS)MYM1999-08-06
208621630809081P970054BIOTRIN PARVOVIRUS B19 IGGMYL1999-08-06
208632031832717P970025PRO-TRAC II TACROLIMUS ELISA KITMLM1999-04-27
208621682233420P890019AB -HAVKLOL1990-07-13
208621423904840P890014HA-IGMK AND ETI-HA-IGMKLOL1990-07-24
208621509363038P250039LIAISON Biotrin Parvovirus B19 IgM Plus, LIAISON Biotrin Control Parvovirus B19 IgM PlusMYM2026-05-07
208621940618408P220034LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG PlusMYL2024-03-29
208621922074656P190017LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory TestLOM2020-08-29
2327251922074656P190017LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory TestLOM2020-08-29
208621172302606P190011LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV AbMZO2019-10-18
2327251172302606P190011LIAISON XL MUREX HCV Ab; LIAISON XL MUREX Control HCV AbMZO2019-10-18
208621951286005P180049LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control anti-HBeSEI2020-08-29
208621796784942P180048LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAgLOM2020-08-29
208621701772719P180047LIAISON QuantiFERON - TB Gold Plus, LIAISON Control QuantiFERON - TB Gold Plus and LIAISON QuantiFERON SoftwareNCD2019-11-26
208621068881130P180045LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgMSEI2020-08-29
208621204890495P180039LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL MUREX Anti-HBs VerifiersSEI2020-02-21
208621314302939P180038LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBcSEI2020-01-02
252461557372733K993754HSV-1 ELISA IGG, MODEL EL0910GMXJ2000-02-09
252461628972947K993724HSV-2 ELISA IGG, MODEL EL0920GMYF2000-02-01
208631154785615K951639COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)DAE1995-10-13
208631410572710K940271INCSTAR ACTH IRMACKG1994-08-02
252461571414717K922374Q FEVER IGM IFA TESTGPJ1992-10-21
252461075099090K913906Q FEVER IGG IFA TESTGPJ1992-10-21
252461407603895K913618ARBOVIRUS IGM IFA TESTGQC1992-12-03
252462041287181K913617ARBOVIRUS IGG IFA TESTGQC1992-12-03
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
252461380677302K864110RICKETTSIAL IGG AND IGM IFA KITGPN1987-03-12
208631707199597K861167IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TESTCZP1986-04-25
208631550988451K822397ANA HEP-2 FLUORO-KITDHN1982-09-21
208631161632615K770057NDNA IMMUNOPATH FLUORO-KITDHN1977-04-05
252461894483267K252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)QOF2025-10-30
252461995260453K251978LIAISON NES FLU A/B, RSV & COVID-19QOF2025-12-23
208621994227741K231214LIAISON VZV IgG HT, LIAISON Control VZV IgG HTLFY2023-10-27
252462032387995K220963Simplexa COVID-19 & Flu A/B DirectQOF2023-03-17
208631328300570K213936LIAISON MeMed BV, LIAISON MeMed BV Control SetQPS2022-07-14
208631282188018K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusNXO2022-07-26
252461855400374K202755Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control PackQDZ2022-11-05
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
252461661132607K201505Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control PackOCC2020-08-22
208621238406707K193650LIAISON FerritinDBF2021-09-14
208621718953468K193532LIAISON Anti-HAV AssayLOL2020-03-02
208631718953468K193532LIAISON Anti-HAV AssayLOL2020-03-02
208631102782292K193051LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control SetLSR2020-01-29
208631391016729K192586LIAISON® FolateCGN2020-05-06
252461390717858K192376Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackPGI2019-11-26
208631702557567K192064LIAISON Vitamin B12CDD2019-10-02
208631626212768K192046LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control SetQFO2019-10-28
252461036042575K190219Simplexa VZV Direct, Simplexa VZV Positive Control PackPLO2019-05-13
208631255469938K182698LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. DeviceNXO2018-12-26
252462015593760K182467Simplexa GBS Direct, Simplexa GBS Positive Control PackNJR2018-11-07
208631867528427K181464LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control SetLYR2018-08-31
208621679333578K173683LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN VerifiersPRI2018-02-27
252461704300095K173498Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackOZZ2018-08-13
252461277011576K163085Simplexa C. difficile Direct; Simplexa C. difficile Positive Control PackOZN2017-02-14
208621101981729K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetLFZ2017-01-06
208621759968133K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control SetLSE2017-01-05
208621685561447K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetLSE2017-01-04
208621867009727K161526LIAISON CMV IgM Serum Control SetJJX2016-06-30
208621989187459K161522LIAISON EBV IgM Serum Control SetJJX2016-06-30
208631989187459K161522LIAISON EBV IgM Serum Control SetJJX2016-06-30
208631843300187K161139LIAISON H. pylori IgG, LIAISON H. pylori IgG Control SetLYR2016-07-22
208621890144761K160650LIAISON HAV IgM, LIAISON Control HAV IgMLOL2016-08-25
252461833890780K152408Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control PackOCC2015-09-21
252461336333436K150962Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackOQO2015-08-28
208631478643684K150879LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration VerifiersCEW2015-06-22
208621900704888K150375LIAISON VZV IgG, LIAISON Control VZV IgGLFY2015-03-11
252461137811977K143651Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackPGX2015-03-18
252461614487850K142365Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control PackOCC2014-12-05
208631390964079K141463LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERSMRG2014-12-10
208621727219480K141116LIAISON XL ANALYZERLOL2014-07-25
208631096573380K132515LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERSCEW2013-11-08
208621568175894K132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IILGD2013-08-28
208621066155279K131441LIAISON TOXO IGM II, LIAISON CONTROL TOXO IGM IILGD2013-08-09
208621775998949K131037LIAISON XL HCGDHA2013-09-06
208621663708361K130469LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3JLW2013-04-05
208632003261686K130321LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERSCJM2013-04-09
208631652003391K122793LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SETCDZ2013-01-25
208621621288630K122397LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMLFX2012-09-06
208621385710348K121951LIAISON FT4 LIAISON CONTROL THYROID 1 LIAISON CONTROL THYROID 2 LIAISON CONTROL THYROID 3CEC2013-04-04
208621721338574K121944LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENTCIB2013-01-01
252461705090881K120986STRATIFY JCV DXSELECTOYP2012-08-16
252461802457899K113433SIMPLEXA C. DIFFICILE UNIVERSAL DIRECTOMN2012-04-04
208621173354803K112725LIAISON 25 OH VITAMIN D TOTAL ASSAYMRG2012-01-20
208631173354803K112725LIAISON 25 OH VITAMIN D TOTAL ASSAYMRG2012-01-20
208621185625522K103529LIAISON XL ANALYZER MODEL 10050LOL2011-01-21
208621295789894K1023143M INTEGRATED CYCLER (110V) & (220V)OOI2010-10-29
2833481295789894K1023143M INTEGRATED CYCLER (110V) & (220V)OOI2010-10-29
252461400457680K1023143M INTEGRATED CYCLER (110V) & (220V)OOI2010-10-29
252461269146393K102170SIMPLEXA FLU A/B & RSVOCC2010-11-24
252462000781051K100148SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500OQW2010-05-24
208631971910078K090104LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603JJX2009-09-09
208621340560358K082050LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGMLOL2008-11-03
208621801889190K082049LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAVLOL2008-12-05
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
208621061492371K073390DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLSLFX2008-11-21
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
208621649892707K061820DIASORIN LIAISON VZV IGGLFY2007-02-26
208621796036534K061247DIASORIN LIAISON TREPONEMA ASSAYLIP2006-07-31
208631796036534K061247DIASORIN LIAISON TREPONEMA ASSAYLIP2006-07-31
208621844247620K060204LIAISON EA IGGLSE2006-10-18
208621327890478K052794ETI-MAX 3000JJF2006-03-31
252461958860710K040854WEST NILE VIRUS IGM CAPTURE ELISANOP2004-06-30
208621161359012K040290DIASORIN LIAISON CMV IGM/IGGLFZ2005-06-01
208622030024880K040120DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYSLLM2005-04-29
252461095298562K031953WEST NILE VIRUS ELISA IGG, MODEL EL0300GNOP2003-10-22
208631129601187K011958CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KITDCN2001-12-04
252461764289249K000238HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900GLGC2000-04-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LOM 72020-08-29
LOL72020-03-02
LSR42021-02-18
OCC42020-08-22
JJX42016-06-30
MRG42014-12-10
QOF32025-12-23
LFY32023-10-27
LSE32017-01-05
OOI32010-10-29
LOM32001-03-30
NXO22022-07-26
LYR22018-08-31
LFZ22017-01-06
CEW22015-06-22
LGD22013-08-28
LFX22012-09-06
MXJ22008-11-18
MYF22008-11-10
LIP22006-07-31
NOP22004-06-30
GQC21992-12-03
GPJ21992-10-21
JZJ21988-11-02
MSJ21987-03-24
DHN21982-09-21
SGW12025-12-23
SBT12024-07-15
QDZ12022-11-05
QPS12022-07-14
DBF12021-09-14
CGN12020-05-06
NCD12019-11-26
PGI12019-11-26
QFO12019-10-28
CDD12019-10-02
PLO12019-05-13
NJR12018-11-07
OZZ12018-08-13
PRI12018-02-27

PMA#

LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM

2022-12-08

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS011 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change...

LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control anti-HBc

2022-12-08

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS014 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change...

LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe

2022-12-08

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS011 Date Received11/10/2022 Decision Date12/08/2022 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/st...

LIAISON® XL MUREX HBeAg and LIAISON® XL MUREX Control HBeAg

2022-12-08

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180048 Supplement NumberS011 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change...

LIAISON® XL MUREX HBsAg Confirmatory

2022-12-08

DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS010 Date Received11/10/2022 Decision Date12/08/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change ...

LIAISON® QuantiFERON TB-Gold Plus assay and Control

2022-07-08

DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS017 Date Received04/13/2022 Decision Date07/08/2022 Product Code NCD  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Chan...

LIAISON® XL MUREX HBc IgM assay and Control

2022-06-23

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS009 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Ch...

LIAISON® XL MUREX Anti-HBs assay, Control and Verifiers

2022-06-23

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS011 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Ch...

LIAISON® XL MUREX Anti-HBc assay and Control

2022-06-23

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS012 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Ch...

LIAISON® XL MUREX HBsAg Qual assay and Control

2022-06-23

DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS006 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Cha...

LIAISON® XL MUREX Anti-HBe assay and Control

2022-06-23

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS009 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Ch...

LIAISON® QuantiFERON TB-Gold Plus assay and Control

2022-06-23

DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS016 Date Received04/05/2022 Decision Date06/23/2022 Product Code NCD  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Proc...

LIAISON® XL MUREX HBeAg assay and Control

2022-06-23

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180048 Supplement NumberS009 Date Received04/05/2022 Decision Date06/23/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Process Ch...

LIAISON® XL MUREX Anti-HBe and LIAISON® XL MUREX Control Anti-HBe

2022-05-06

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS008 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change...

LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM

2022-05-06

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS008 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change...

LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX Control Anti-HBc

2022-05-06

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS011 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change...

LIAISON® XL MUREX HBeAg and LIAISON00 XL MUREX Control HBeAg

2022-05-06

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180048 Supplement NumberS008 Date Received04/05/2022 Decision Date05/06/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change...

LIAISON® XL MUREX Anti-HBs assay, Control and Verifiers

2022-05-05

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS009 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Des...

LIAISON® XL MUREX HBeAg assay and Control

2022-05-05

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180048 Supplement NumberS007 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Des...

LIAISON®XL MUREX Anti-HBc assay and Control

2022-05-05

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180038 Supplement NumberS010 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Des...

LIAISON® XL MUREX HBsAg Qual assay and Control

2022-05-05

DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS004 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Desi...

LIAISON® XL MUREX Anti-HBe assay and Control

2022-05-05

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180049 Supplement NumberS007 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Des...

LIAISON® QuantiFERON TB-Gold Plus assay and Control

2022-05-05

DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS014 Date Received02/04/2022 Decision Date05/05/2022 Product Code NCD  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Chan...

LIAISON® XL MUREX HBc lgM assay and Control

2022-05-05

DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180045 Supplement NumberS007 Date Received02/04/2022 Decision Date05/05/2022 Product Code LOM  Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Des...

200 records. Showing 1-40. Next

PMN#

83 records. Showing 1-40. Next

GUDID#

90 records. Showing 1-40. Next