Instrumentation Laboratory SpA

Matched from indexed company URL: INSTRUMENTATION LABORATORY SPA

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3007719797	3007719797	Instrumentation Laboratory SpA	1	N	2026-01-01	Zona Industriale Campolungo 327a, 11 Ascoli Piceno Marche IT 63100
3012348571	3012348571	INSTRUMENTATION LABORATORY SPA	1	N	2026-01-01	Via Leonardo da Vinci, 36 Roncello Lombardy IT 20877

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
298690	1092273400	K993727	BINDAZYME ANTI-DSDNA EIA KIT	LRM	1999-12-21
298690	1308211388	K991657	QUANTA LITE ANA ELISA	LLL	1999-06-17
298690	1337560613	K984336	QUANTA LITE GBM ELISA	MVJ	1999-02-08
298690	1394976997	K983084	QUANTA LITE RF IGA ELISA	DHR	1998-11-04
298690	1763285732	K983083	QUANTA LITE RF IGG ELISA	DHR	1998-11-04
298690	1891052831	K982790	QUANTA LITE H. PYLORI IGG ELISA	LYR	1998-11-04
298690	1814660777	K982603	QUANTA LITE CHROMATIN ELISA	LLL	1998-10-07
298690	1738934928	K982366	QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA	MVM	1998-08-27
298690	1566074643	K981857	QUANTA LITE TPO ELISA	LLL	1998-07-29
298690	2018109715	K981330	QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT	MOB	1998-06-19
298690	1135623576	K981328	QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT	MOB	1998-06-19
298690	1927243324	K981237	QUANTA LITE RIBOSOME P ELISA	MQA	1998-06-05
298690	1639793294	K981209	MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS	MVM	1998-10-22
298690	1813311170	K981029	BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT	MOB	1998-07-20
298690	1495416029	K980230	QUANTA LITE B2 GPI SCREEN	MSV	1998-03-24
298690	1751965225	K973014	QUANTA LITE B2GPI IGM	MSV	1997-10-20
298690	1129505614	K973006	QUANTA LITE B2 GPI IGA	MSV	1997-10-20
298690	1811043826	K971614	QUANTA LITE RF IGM	DHR	1997-06-20
298690	1229389576	K970551	QUANTA LITE B2GPI IGG	MSV	1997-06-24
298690	1865053459	K965133	ANCA COMBI DIAGNOSTIC TEST KIT	MOB	1997-05-21
298690	1325076170	K964986	QUANTA LITE IGA GLIADIN ELISA	MST	1997-06-02
298690	1810512599	K964985	QUANTA LITE IGG GLIADIN ELISA	MST	1997-05-30
298690	1168067885	K961913	QUANTA LITE ENA 6 ELISA	LLL	1996-07-10
298690	1935655852	K961340	NOVA LITE ANCA	MOB	1996-07-10
298690	1019054924	K955431	RIT LIVER, KIDNEY, STOMACH IFA KIT	DBL	1996-04-23
298690	1443666634	K953366	QUANTA LITE IGA ACA (HRP)	MID	1995-09-01
298690	1584712721	K953291	QUANTA LITE ACA SCREEN (HRP)	MID	1995-08-29
298690	1715005655	K946385	QUANTA LITE ACA IGM (HRP)	MID	1995-07-18
298690	1118371039	K946034	QUANTA LITE(TM) IGG (HRP)	MID	1995-07-18
298690	1969843873	K943076	QUANTA LITE ENA 5 ELISA KIT	LLL	1994-10-25
298690	1968814310	K934053	QUANTA LITE(TM) HISTONE ELISA	LLL	1993-12-21
298690	1844460183	K930486	QUANTA LITE(TM) THYROID T ELISA	DDC	1993-03-15
298690	1046092824	K926562	QUANTA LITE(TM) JO-1 ELISA KIT	LLL	1993-03-04
298690	1311198195	K924898	QUANTA LITE(TM) SCL-70 ELISA	LLL	1992-12-15
298690	1420877028	K922833	QUANTA LITE RNP ELISA	LLL	1992-09-18
298690	1333687217	K922832	QUANTA LITE SS-B ELISA	LLL	1992-09-18
298690	1741157067	K922831	QUANTA LITE SM ELISA	LLL	1992-09-18
298690	1848683790	K922830	QUANTA LITE SS-A ELISA	LLL	1992-09-18
298690	2036680537	K922829	QUANTA LITE ENA ELISA	LLL	1992-09-18
298690	1593626931	K922075	AVOXIMETER	DQA	1992-11-04
298690	2063829050	K903898	QUANTA LITE TM DSDNA	LLL	1990-09-05
298690	1702175032	K901596	NOVA LITE(TM) ANA KSL	DHN	1990-05-02
298690	1423144369	K881340	NOVA LITE(TM) AUTOANTIBODY CONTROLS	LLL	1988-06-08
298690	1298943137	K881339	NOVA LITE(TM) ANA PLUS	LLL	1988-04-21
298690	1978081314	K880742	NOVA LITE(TM) DSDNA	DHN	1988-03-25
298690	1247354049	K880736	NOVA LITE(TM) ANA	LLL	1988-03-25
298690	1233397044	K223352	Tenderfoot	FMK	2023-03-02
298690	1532868014	K193041	Hemochron Signature Elite	JPA	2019-11-22
298690	2023151601	K170314	ACL AcuStar	JPA	2017-03-03
298690	1985676013	K141210	QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS	LLL	2015-01-29
298690	1938722701	K123880	QUANTA FLASH CENTROMERE	LJM	2014-02-07
298690	1682890031	K123593	QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,	LKP	2013-04-17
298690	1264747786	K122923	QUANTA FLASH ENA7	LLL	2013-05-07
298690	1252751844	K120817	QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA	MID	2013-02-26
298690	1685706791	K113863	QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS	MST	2012-09-20
298690	1570580908	K112545	QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM	MOB	2012-07-31
298690	1953406824	K111414	QUANTA FLASH (TM) DGP SCREEN	MST	2011-10-20
298690	1601591861	K101644	QUANTA FLASH H-TTG IGG	MVM	2011-03-23
298690	2019461283	K101533	EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM	JPA	2011-08-10
298690	1572690179	K094060	QUANTA FLASH H-TTG IGA	MVM	2010-10-13
298690	1187689238	K092181	HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS	MID	2010-03-11
298690	1868993764	K091556	HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS	MSV	2010-05-21
298690	1392525666	K090755	QUANTA LITE APS/PT IGG AND IGM ELISA	OPN	2010-02-01
298690	1311462835	K083842	ROTEM DELTA THROMBOELASTOMETRY SYSTEM	JPA	2010-03-23
298690	1124426151	K073145	QUANTA LITE H-TTG SCREEN	MVM	2008-02-12
298690	1434341438	K072967	QUANTA LITE F-ACTIN IGA ELISA	MVM	2008-01-28
298690	1013575720	K072944	QUANTA LITE CCP3.1 IGG/IGA ELISA	NHX	2008-03-05
298690	1355583266	K070083	QUANTA LITE H-TTG/DGP SCREEN	MST	2007-03-12
298690	1777840293	K062708	QUANTA LITE CELIAC DGP SCREEN	MST	2006-12-13
298690	1514979901	K062183	FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT	LRM	2006-11-21
298690	1432383573	K061842	QUANTA LITE PBC SCREEN IGG/IGA ELISA	NRI	2006-10-18
298690	1937802621	K052264	QUANTA LITE CCP3 IGG ELISA	NHX	2005-11-23
298690	1469001624	K052262	QUANTA LITE M2 EP (MIT3) ELISA	DBM	2005-10-27
298690	1570360775	K052143	QUANTA LITE GLIADIN IGA II	MST	2005-10-04
298690	1482887225	K052142	QUANTA LITE GLIADIN IGG II	MST	2005-10-04
298690	2038449671	K040885	QUANTA LITE GP210 ELISA	NRI	2004-06-25
298690	1980594397	K040466	BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS	MVM	2004-07-16
298690	1615711856	K032240	BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT	MID	2003-09-29
298690	1720221733	K031563	BINDAZYME CLQ CIC EIA KIT	DAK	2003-09-10
298690	1300287843	K024334	QUANTA LITE H.PYLORI IGA ELISA	LYR	2003-03-27
298690	1553846976	K021648	QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA	NJF	2002-09-20
298690	1908052721	K021482	QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA	NIY	2002-07-30
298690	1533182602	K011570	QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA	MVM	2001-07-09
298690	1179687065	K011566	QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA	MVM	2001-07-09
298690	1867868997	K010558	QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA	MLE	2001-04-03
298690	1617994521	K003959	QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA	LJM	2001-01-22
298690	1133300601	K000733	QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA	NBT	2001-05-21
298690	1176351624	K000535	QUANTA LITE LKM-1 ELISA	NBS	2000-06-07
298690	1961026819	DEN000007	QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA	NBT	2000-08-16
298690	1031955361
297349	1031955361
297349	2023151601

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
LLL	19	2015-01-29
MVM	9	2011-03-23
MST	8	2012-09-20
MID	7	2013-02-26
MOB	6	2012-07-31
MSV	5	2010-05-21
JPA	4	2019-11-22
DHR	3	1998-11-04
LJM	2	2014-02-07
NHX	2	2008-03-05
LRM	2	2006-11-21
NRI	2	2006-10-18
LYR	2	2003-03-27
NBT	2	2001-05-21
DHN	2	1990-05-02
FMK	1	2023-03-02
LKP	1	2013-04-17
OPN	1	2010-02-01
DBM	1	2005-10-27
DAK	1	2003-09-10
NJF	1	2002-09-20
NIY	1	2002-07-30
MLE	1	2001-04-03
NBS	1	2000-06-07
MVJ	1	1999-02-08
MQA	1	1998-06-05
DBL	1	1996-04-23
DDC	1	1993-03-15
DQA	1	1992-11-04