DiaSorin Molecular LLC

Matched from indexed company URL: DIASORIN INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2023365	2023365	DiaSorin Molecular LLC	1	Y	2026-01-01	11331 Valley View St CYPRESS CA US 90630
2182595	2182595	DIASORIN INC.	1	Y	2026-01-01	1951 Northwestern Ave Stillwater MN US 55082
3012449645	3012449645	DiaSorin Canada Inc.	1	N	2026-01-01	5075 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 GUDID	Product	Phone	Email
08056771600811	ANAFLUOR™ - 1662	651-439-9710	info@diasorin.com
08056771600828	ANAFLUOR™ - 1660	651-439-9710	info@diasorin.com
08056771600835	ANAFLUOR ™ - 1624	651-439-9710	info@diasorin.com
08056771600842	ANAFLUOR™ - 6624	651-439-9710	info@diasorin.com

diasorin.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
20863	2031832717	P970025	PRO-TRAC II TACROLIMUS ELISA KIT	MLM	1999-04-27
25246	1557372733	K993754	HSV-1 ELISA IGG, MODEL EL0910G	MXJ	2000-02-09
25246	1628972947	K993724	HSV-2 ELISA IGG, MODEL EL0920G	MYF	2000-02-01
20863	1154785615	K951639	COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)	DAE	1995-10-13
20863	1410572710	K940271	INCSTAR ACTH IRMA	CKG	1994-08-02
25246	1571414717	K922374	Q FEVER IGM IFA TEST	GPJ	1992-10-21
25246	1075099090	K913906	Q FEVER IGG IFA TEST	GPJ	1992-10-21
25246	1407603895	K913618	ARBOVIRUS IGM IFA TEST	GQC	1992-12-03
25246	2041287181	K913617	ARBOVIRUS IGG IFA TEST	GQC	1992-12-03
20863	1805955769	K892526	SPQ TM TEST SYSTEM II FOR CRP	DCK	1989-05-09
20863	1653695814	K884298	SPQ(TM) TEST SYSTEM FOR MICROALBUMIN	JZJ	1988-11-02
20863	1832668476	K884297	SPQ(TM) TEST SYSTEM FOR PREALBUMIN	JZJ	1988-11-02
20863	1246560884	K870862	SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN AL	MSJ	1987-03-24
20863	1224277754	K870564	SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B	MSJ	1987-03-24
25246	1380677302	K864110	RICKETTSIAL IGG AND IGM IFA KIT	GPN	1987-03-12
20863	1707199597	K861167	IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST	CZP	1986-04-25
20863	1550988451	K822397	ANA HEP-2 FLUORO-KIT	DHN	1982-09-21
20863	1161632615	K770057	NDNA IMMUNOPATH FLUORO-KIT	DHN	1977-04-05
25246	1296930277	K260333	LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit	PGX	2026-06-15
25246	1894483267	K252387	Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)	QOF	2025-10-30
25246	1995260453	K251978	LIAISON NES FLU A/B, RSV & COVID-19	QOF	2025-12-23
25246	2032387995	K220963	Simplexa COVID-19 & Flu A/B Direct	QOF	2023-03-17
20863	1328300570	K213936	LIAISON MeMed BV, LIAISON MeMed BV Control Set	QPS	2022-07-14
20863	1282188018	K213858	LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus	NXO	2022-07-26
25246	1855400374	K202755	Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack	QDZ	2022-11-05
20863	1980493973	K202574	LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus	LSR	2021-02-18
20863	1556185290	K202573	LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus	LSR	2021-02-18
25246	1661132607	K201505	Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack	OCC	2020-08-22
20863	1718953468	K193532	LIAISON Anti-HAV Assay	LOL	2020-03-02
20863	1102782292	K193051	LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set	LSR	2020-01-29
20863	1391016729	K192586	LIAISON® Folate	CGN	2020-05-06
25246	1390717858	K192376	Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack	PGI	2019-11-26
20863	1702557567	K192064	LIAISON Vitamin B12	CDD	2019-10-02
20863	1626212768	K192046	LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set	QFO	2019-10-28
25246	1036042575	K190219	Simplexa VZV Direct, Simplexa VZV Positive Control Pack	PLO	2019-05-13
20863	1255469938	K182698	LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device	NXO	2018-12-26
25246	2015593760	K182467	Simplexa GBS Direct, Simplexa GBS Positive Control Pack	NJR	2018-11-07
20863	1867528427	K181464	LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set	LYR	2018-08-31
25246	1704300095	K173498	Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack	OZZ	2018-08-13
25246	1277011576	K163085	Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack	OZN	2017-02-14
20863	1989187459	K161522	LIAISON EBV IgM Serum Control Set	JJX	2016-06-30
20863	1843300187	K161139	LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set	LYR	2016-07-22
25246	1833890780	K152408	Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack	OCC	2015-09-21
25246	1336333436	K150962	Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack	OQO	2015-08-28
20863	1478643684	K150879	LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers	CEW	2015-06-22
25246	1137811977	K143651	Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack	PGX	2015-03-18
25246	1614487850	K142365	Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack	OCC	2014-12-05
20863	1390964079	K141463	LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS	MRG	2014-12-10
20863	1096573380	K132515	LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS	CEW	2013-11-08
20863	2003261686	K130321	LIAISON ALDOSTERONE, LIAISON ALDOSTERONE CONTROL SET, LIAISON ALDOSTERONE CALIBRATION VERIFIERS	CJM	2013-04-09
20863	1652003391	K122793	LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET	CDZ	2013-01-25
25246	1705090881	K120986	STRATIFY JCV DXSELECT	OYP	2012-08-16
25246	1802457899	K113433	SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT	OMN	2012-04-04
20863	1173354803	K112725	LIAISON 25 OH VITAMIN D TOTAL ASSAY	MRG	2012-01-20
283348	1295789894	K102314	3M INTEGRATED CYCLER (110V) & (220V)	OOI	2010-10-29
25246	1400457680	K102314	3M INTEGRATED CYCLER (110V) & (220V)	OOI	2010-10-29
25246	1269146393	K102170	SIMPLEXA FLU A/B & RSV	OCC	2010-11-24
25246	2000781051	K100148	SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500	OQW	2010-05-24
20863	1971910078	K090104	LIAISON 25 OH VITAMIN D TOTAL CALIBRATION VERIFIERS, MODEL: 310603	JJX	2009-09-09
20863	1390219823	K081687	LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG	MYF	2008-11-10
20863	1932376065	K081685	LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG	MXJ	2008-11-18
20863	1575319401	K071480	LIAISON 25 OH VITAMIN D TOTAL; ASSAY, CONTROL SET AND SPECIMEN DILUENT SET, MODELS 310600, 310601 AND 310602	MRG	2007-10-01
20863	1187984510	K062473	LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871	LSR	2007-04-12
20863	1796036534	K061247	DIASORIN LIAISON TREPONEMA ASSAY	LIP	2006-07-31
25246	1958860710	K040854	WEST NILE VIRUS IGM CAPTURE ELISA	NOP	2004-06-30
25246	1095298562	K031953	WEST NILE VIRUS ELISA IGG, MODEL EL0300G	NOP	2003-10-22
20863	1129601187	K011958	CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT	DCN	2001-12-04
25246	1764289249	K000238	HSV-1 & HSV-2 DIFFERENTIATION IMMUNOBLOT IGG, MODEL IB0900G	LGC	2000-04-14
25246	1644229901	DEN230092	Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)	SBT	2024-07-15
25246	1735830834	DEN130049	SIMPLEXA HSV 1&2 DIRECT	PGH	2014-03-21
20863	1136655348
20863	1359621722
20863	1397947731
20863	1473221331
20863	1628798923
25246	1674454346
20863	1727362201
20863	1736188029
25246	1800404715
25246	1912706310
20863	2045646043
25246	1033690984
20863	1045112315
20863	1059055552
20863	1132845419
25246	1135845099
25246	1189548520
20863	1205340820
25246	1206087844
20863	1226592488
25246	1244189346
25246	1289510058
20863	1304236437
20863	1336532726
25246	1355481568
20863	1358746476
25246	1366453027
20863	1409182786
20863	1410361514
20863	1415813938
25246	1433981992
25246	1481289067
20863	1596161468
25246	1612470265
20863	1658312498
25246	1672375921
20863	1701772719
20863	1737223313
20863	1761343219
20863	1791460869
20863	1801195120
20863	1828606535
25246	1839319975
25246	1846624837
20863	1854203955
20863	1878287208
20863	1882729186
25246	1892445004
20863	1905312439

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LSR	4	2021-02-18
OCC	4	2020-08-22
QOF	3	2025-12-23
MRG	3	2014-12-10
PGX	2	2026-06-15
NXO	2	2022-07-26
LYR	2	2018-08-31
JJX	2	2016-06-30
CEW	2	2015-06-22
OOI	2	2010-10-29
MXJ	2	2008-11-18
MYF	2	2008-11-10
NOP	2	2004-06-30
GQC	2	1992-12-03
GPJ	2	1992-10-21
JZJ	2	1988-11-02
MSJ	2	1987-03-24
DHN	2	1982-09-21
SBT	1	2024-07-15
QDZ	1	2022-11-05
QPS	1	2022-07-14
CGN	1	2020-05-06
LOL	1	2020-03-02
PGI	1	2019-11-26
QFO	1	2019-10-28
CDD	1	2019-10-02
PLO	1	2019-05-13
NJR	1	2018-11-07
OZZ	1	2018-08-13
OZN	1	2017-02-14
OQO	1	2015-08-28
PGH	1	2014-03-21
CJM	1	2013-04-09
CDZ	1	2013-01-25
OYP	1	2012-08-16
OMN	1	2012-04-04
OQW	1	2010-05-24
LIP	1	2006-07-31
DCN	1	2001-12-04
LGC	1	2000-04-14

PMA#

LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test
2022-12-21
DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS008 Date Received09/21/2022 Decision Date12/21/2022 Product Code LOM Advisory Committee Microbiology Supplement Typereal-time Process Supplement Reason Change Desi...
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers
2022-12-08
DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS013 Date Received11/10/2022 Decision Date12/08/2022 Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/st...
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® QuantiFERON®-TB Gold Plus and LIAISON® XL Control QuantiFERON®-TB Gold Plus
2022-12-08
DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS022 Date Received11/10/2022 Decision Date12/08/2022 Product Code NCD Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process ...
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, LIAISON Control QuantiFERON - TB Gold Plus
2022-08-11
DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS018 Date Received07/15/2022 Decision Date08/11/2022 Product Code NCD Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process ...
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® QuantiFERON-TB Gold Plus and LIAISON® XL Control QuantiFERON-TB Gold Plus
2022-05-06
DiaSorin, Inc.1951 Northwestern Avenuestillwater, MN 55082-0285 PMA NumberP180047 Supplement NumberS015 Date Received04/05/2022 Decision Date05/06/2022 Product Code NCD Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process ...
LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual
2022-05-06
DiaSorin Inc1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP190017 Supplement NumberS005 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, LIAISON® XL MUREX Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifier
2022-05-06
DiaSorin Inc.1951 Northwestern Avenuestillwater, MN 55082 PMA NumberP180039 Supplement NumberS010 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...
LIAISON® XL MUREX HBsAg Qual, LIAISON® XL MUREX Control HBsAg Qual
2022-01-21
DiaSorin Inc
LIAISON® XL Murex Anti-HBc and LIAISON® XL Murex Control Anti-HBc
2021-12-27
DiaSorin Inc.
LIAISON® XL Murex HBeAg and LIAISON® XL Murex Control HBeAg
2021-12-27
DiaSorin Inc.
LIAISON® XL Murex HBc IgM and LIAISON® XL Murex Control HBc IgM
2021-12-27
DiaSorin Inc.
LIAISON® XL Murex Anti-HBs, LIAISON® XL Murex Control Anti-HBs and LIAISON® XL Murex Anti-HBs Verifiers
2021-12-27
DiaSorin Inc.
ETI-CORE-IGMK PLUS assay
2021-12-21
DIASORIN, INC.
ETI-AB-AUK PLUS assay
2021-12-21
DIASORIN, INC.
LIAISON® XL MUREX HBc IgM and LIAISON® XL MUREX Control HBc IgM
2021-12-21
DiaSorin Inc.
ETI-MAK-2 PLUS and HBsAg Confirmatory Test assay
2021-12-21
DIASORIN, INC.

200 records. Showing 1-40. Next

PMN#

LIAISON NES FLU A/B, RSV & COVID-19
2025-12-23
Diasorin Molecular, LLC
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
2023-10-27
DiaSorin, Inc.
Simplexa COVID-19 & Flu A/B Direct
2023-03-17
Diasorin Molecular, LLC
LIAISON Anti-HAV; LIAISON XS
2022-12-09
DiaSorin Inc.
Simplexa Congenital CMV Direct And Simplexa Congenital CMV Positive Control Pack
2022-11-05
DiaSorin Molecular LLC
Simplexa COVID-19 Direct
2022-09-13
Diasorin Molecular, LLC
LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus
2022-07-26
DiaSorin Inc.
LIAISON MeMed BV, LIAISON MeMed BV Control Set
2022-07-14
DiaSorin Inc.
LIAISON Ferritin
2021-09-14
DiaSorin, Inc.
LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
2021-02-18
DiaSorin Inc.
LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
2021-02-18
DiaSorin Inc.
LIAISON Anti-HAV
2021-02-09
DiaSorin, Inc.
LIAISON Testosterone Xt
2020-10-15
DiaSorin Inc.
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack
2020-08-22
DiaSorin Molecular LLC
LIAISON® Folate
2020-05-06
Diasorin Inc.
LIAISON Anti-HAV Assay
2020-03-02
DiaSorin Inc.
LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set
2020-01-29
DiaSorin Inc.
Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack
2019-11-26
DiaSorin Molecular LLC
LIAISON XL Zika Capture IgM II And LIAISON XL Zika Capture IgM II Control Set
2019-10-28
DiaSorin Inc.
LIAISON Vitamin B12
2019-10-02
DiaSorin Inc.
Simplexa VZV Direct, Simplexa VZV Positive Control Pack
2019-05-13
DiaSorin Molecular LLC
LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device
2018-12-26
DiaSorin Inc.
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
2018-12-19
DiaSorin Molecular LLC
Simplexa GBS Direct, Simplexa GBS Positive Control Pack
2018-11-07
DiaSorin Molecular LLC
LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set
2018-08-31
DiaSorin Inc.
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
2018-08-13
DiaSorin Molecular LLC
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
2018-03-14
DiaSorin Molecular LLC
LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers
2018-02-27
DiaSorin Inc.
LIAISON® CMV IgG And LIAISON® CMV IgG Serum Control Set
2017-01-06
DiaSorin Inc.
LIAISON® VCA IgG And LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG And LIAISON® EBNA IgG Serum Control Set
2017-01-05
DIASORIN INC.
LIAISON® EA IgG And LIAISON® EA IgG Serum Control Set
2017-01-04
DIASORIN INC.
LIAISON HAV IgM, LIAISON Control HAV IgM
2016-08-25
DiaSorin Inc.
LIAISON H. Pylori IgG, LIAISON H. Pylori IgG Control Set
2016-07-22
DIASORIN, INC.
LIAISON CMV IgM Serum Control Set
2016-06-30
DiaSorin Inc.
LIAISON EBV IgM Serum Control Set
2016-06-30
DiaSorin Inc.
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers
2015-06-22
DiaSorin Inc.
LIAISON VZV IgG, LIAISON Control VZV IgG
2015-03-11
DiaSorin Inc.
LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS
2014-12-10
DiaSorin Inc.
LIAISON XL ANALYZER
2014-07-25
DIASORIN, INC.
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
2013-11-08
DIASORIN, INC.

83 records. Showing 1-40. Next

GUDID#

LIAISON QuantiFERON TB Gold Plus II - US manufactured kit
Diasorin Inc.
2026-02-20
LIAISON QuantiFERON TB Gold Plus II - US manufactured kit
Diasorin Inc.
2026-02-20
LIAISON Control QuantiFERON TB Gold Plus II - US Manufactured Kit
Diasorin Inc.
2026-02-20
LIAISON QuantiFERON TB Gold Plus II - US manufactured kit
Diasorin Inc.
2026-02-19
ANAFLUOR™ - 1662
Diasorin Inc.
2016-09-24
ANAFLUOR™ - 1660
Diasorin Inc.
2016-09-24
ANAFLUOR ™ - 1624
Diasorin Inc.
2016-09-24
ANAFLUOR™ - 6624
Diasorin Inc.
2016-09-24
ANAFAST™ ANA Fluorescent Test System 240 Wells - 1670
Diasorin Inc.
2016-09-24
CT-3 Immunoscreen Fluoro-Kit™ - 1740
Diasorin Inc.
2016-09-24
CT-2 Immunoscreen Fluoro-Kit™ - 1741
Diasorin Inc.
2016-09-24
RS Fluoro-Kit™ - 1970
Diasorin Inc.
2016-09-24
ANAFLUOR™ Combo-Pak - 1812
Diasorin Inc.
2016-09-24
ANA HEp-2 6-well Slide Pack - 1663
Diasorin Inc.
2016-09-24
ANA HEp-2 12-well Slide Pack - 1661
Diasorin Inc.
2016-09-24
CT-3 6-well Slide Pack - 1801
Diasorin Inc.
2016-09-24
CT-2 Slide Pack - 1631
Diasorin Inc.
2016-09-24
Fluorescent Antibody (HEp-2) Conjugate - 1664
Diasorin Inc.
2016-09-24
LIAISON® Control HSV-2 IgG - 310621
Diasorin Inc.
2016-09-24
LIAISON 25 OH Vitamin D Total Assay 200 test - 318360
Diasorin Inc.
2021-04-13
LIAISON® 25 OH Vitamin D TOTAL Assay - 310600
Diasorin Inc.
2016-09-24
LIAISON® 25 OH Vitamin D TOTAL Control Set - 310601
Diasorin Inc.
2016-09-24
LIAISON® 25 OH Vitamin D TOTAL Assay Specimen Diluent - 310602
Diasorin Inc.
2016-09-24
LIAISON® 25 OH Vitamin D TOTAL Calibration Verifiers - 310603
Diasorin Inc.
2016-09-24
LIAISON® HSV-2 Type Specific IgG - 310620
Diasorin Inc.
2016-09-24
LIAISON® HSV-1 Type Specific IgG - 310830
Diasorin Inc.
2016-09-24
LIAISON® Control HSV-1 IgG - 310831
Diasorin Inc.
2016-09-24
LIAISON QUANTIferon TB Gold Plus - USA manufactured kit
Diasorin Inc.
2023-09-08
LIAISON Elastase-1 - 319140
Diasorin Inc.
2019-05-24
LIAISON Testosterone xt Control - 318411
Diasorin Inc.
2021-05-04
LIAISON Testosterone xt - 318410
Diasorin Inc.
2021-04-13
LIAISON Control QUANTIferon TB Gold Plus - USA manufactured control kit
Diasorin Inc.
2023-09-08
LIAISON QUANTIferon TB Gold Plus - US manufactured kit
Diasorin Inc.
2023-07-21
LIAISON® Testosterone - 310410
Diasorin Inc.
2016-09-24
LIAISON® Testosterone Control Set - 310411
Diasorin Inc.
2016-09-24
LIAISON MeMed BV - The DiaSorin LIAISON MeMed BV is a semi-quantitative assay that uses chemiluminescent immunoassay (CLIA) technology to measure three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples.
Diasorin Inc.
2022-08-10
LIAISON MeMed BV Control Set - The DiaSorin LIAISON MeMed BV Control Set is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® MeMed BV assay.
Diasorin Inc.
2022-08-10
LIAISON Q.S.E.T. Device Plus - Fecal extraction device
Diasorin Inc.
2022-08-09
LIAISON® Vitamin B12 - 318320
Diasorin Inc.
2019-12-04
LIAISON® Vitamin B12 Control Set - 318321
Diasorin Inc.
2019-12-04

90 records. Showing 1-40. Next