FDA.report

INSTRUMENTATION LABORATORY CO.

Matched from indexed company URL: Instrumentation Laboratory Company

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
12171831217183INSTRUMENTATION LABORATORY CO.1N2026-01-01180 Hartwell Rd. Bedford MA US 01730
24315302431530INSTRUMENTATION LABORATORY CO.1Y2026-01-01526 Route 303 ORANGEBURG NY US 10962
30077197973007719797Instrumentation Laboratory SpA1N2026-01-01Zona Industriale Campolungo 327a, 11 Ascoli Piceno Marche IT 63100
30123485713012348571INSTRUMENTATION LABORATORY SPA1N2026-01-01Via Leonardo da Vinci, 36 Roncello Lombardy IT 20877
30370006373037000637INSTRUMENTATION LABORATORY CO. - Devens1Y2026-01-0111 Grant Road Devens MA US 01434
30127753503012775350Instrumentation Laboratory Co.1Y2020-04-2518B Independence Dr Devens MA US 01434

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
00195226000528ACL TOP 770 - 00000280057800-678-0710techsupport.na@werfen.com
00195226000535ACL TOP 770 LAS - 00000280037800-678-0710techsupport.na@werfen.com
00195226000542ACL TOP 770s - 00000280017800-678-0710techsupport.na@werfen.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2986901092273400K993727BINDAZYME ANTI-DSDNA EIA KITLRM1999-12-21
299661772099938K992834GEM PREMIER 3000CHL1999-11-24
1978361772099938K992834GEM PREMIER 3000CHL1999-11-24
3376461772099938K992834GEM PREMIER 3000CHL1999-11-24
299601885556154K992704IL TEST VON WILLEBRAND FACTORGGP1999-11-01
1978361885556154K992704IL TEST VON WILLEBRAND FACTORGGP1999-11-01
299601401783295K992531ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEMJOZ1999-12-20
2986901308211388K991657QUANTA LITE ANA ELISALLL1999-06-17
299601271017991K990449HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBEJPA1999-04-13
2986901337560613K984336QUANTA LITE GBM ELISAMVJ1999-02-08
299601496326083K983475HEMOCHRON RESPONSEKQG1999-05-03
299661312297936K983178COAMATIC HEPARINKFF1998-11-03
3376461312297936K983178COAMATIC HEPARINKFF1998-11-03
2986901394976997K983084QUANTA LITE RF IGA ELISADHR1998-11-04
2986901763285732K983083QUANTA LITE RF IGG ELISADHR1998-11-04
2986901891052831K982790QUANTA LITE H. PYLORI IGG ELISALYR1998-11-04
2986901814660777K982603QUANTA LITE CHROMATIN ELISALLL1998-10-07
2986901738934928K982366QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISAMVM1998-08-27
2986901566074643K981857QUANTA LITE TPO ELISALLL1998-07-29
299661149139197K981696IL TEST PLASMIN INHIBITORGGP1998-08-27
1978361149139197K981696IL TEST PLASMIN INHIBITORGGP1998-08-27
3376461149139197K981696IL TEST PLASMIN INHIBITORGGP1998-08-27
2986902018109715K981330QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KITMOB1998-06-19
2986901135623576K981328QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KITMOB1998-06-19
2986901927243324K981237QUANTA LITE RIBOSOME P ELISAMQA1998-06-05
2986901639793294K981209MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITSMVM1998-10-22
299661081003293K981200IL TEST PLASMINOGENGGP1998-05-26
1978361081003293K981200IL TEST PLASMINOGENGGP1998-05-26
3376461081003293K981200IL TEST PLASMINOGENGGP1998-05-26
299661777208646K981038COAMATIC FACTOR VIIIGGP1998-04-16
3376461777208646K981038COAMATIC FACTOR VIIIGGP1998-04-16
2986901813311170K981029BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KITMOB1998-07-20
299661968806649K980242IL TEST HEPARINKFF1998-03-19
1978361968806649K980242IL TEST HEPARINKFF1998-03-19
3376461968806649K980242IL TEST HEPARINKFF1998-03-19
2986901495416029K980230QUANTA LITE B2 GPI SCREENMSV1998-03-24
299661894707789K973306IL TEST APTT-SPGFO1997-11-04
1978361894707789K973306IL TEST APTT-SPGFO1997-11-04
2986901751965225K973014QUANTA LITE B2GPI IGMMSV1997-10-20
2986901129505614K973006QUANTA LITE B2 GPI IGAMSV1997-10-20
299601946200015K972866HEMOCHRON JR. MIOCROCOAGULATION CITRATED PTGJS1998-09-30
299601800955778K972831HEMOCHRON CITRATE APTTGFO1997-11-20
2986901811043826K971614QUANTA LITE RF IGMDHR1997-06-20
2986901229389576K970551QUANTA LITE B2GPI IGGMSV1997-06-24
2986901865053459K965133ANCA COMBI DIAGNOSTIC TEST KITMOB1997-05-21
2986901325076170K964986QUANTA LITE IGA GLIADIN ELISAMST1997-06-02
2986901810512599K964985QUANTA LITE IGG GLIADIN ELISAMST1997-05-30
299661895954946K963902QUANTITATIVE FIBRINOGEN ASSAYGIS1996-11-29
1978361895954946K963902QUANTITATIVE FIBRINOGEN ASSAYGIS1996-11-29
3376461895954946K963902QUANTITATIVE FIBRINOGEN ASSAYGIS1996-11-29
299661832492369K963111COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V SGGW1996-12-23
1978361832492369K963111COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V SGGW1996-12-23
3376461832492369K963111COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V SGGW1996-12-23
299601403472116K961991ACL 6000 SYSTEM (ACL 6000)GKP1996-09-04
2986901168067885K961913QUANTA LITE ENA 6 ELISALLL1996-07-10
2986901935655852K961340NOVA LITE ANCAMOB1996-07-10
299601656766759K960749HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACTJBP1996-08-12
299661681254823K955638SYNTHAFAX APTT REAGENTGFO1996-04-23
3376461681254823K955638SYNTHAFAX APTT REAGENTGFO1996-04-23
2986901019054924K955431RIT LIVER, KIDNEY, STOMACH IFA KITDBL1996-04-23
2986901443666634K953366QUANTA LITE IGA ACA (HRP)MID1995-09-01
2986901584712721K953291QUANTA LITE ACA SCREEN (HRP)MID1995-08-29
299601095726868K951485AVOXIMETER 4000JKS1995-11-06
2986901715005655K946385QUANTA LITE ACA IGM (HRP)MID1995-07-18
2986901118371039K946034QUANTA LITE(TM) IGG (HRP)MID1995-07-18
299661824544598K945940COATEST(R) APC(TM) RESISTANCEGGW1995-08-07
3376461824544598K945940COATEST(R) APC(TM) RESISTANCEGGW1995-08-07
299601536383987K944691ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR IIGGN1995-03-15
2986901969843873K943076QUANTA LITE ENA 5 ELISA KITLLL1994-10-25
299601292766525K941007CATALOG NO. J-ACT+ & QC-ACT+JBP1994-06-30
299601426950604K940432MICROCOAGULATION PROTHROMBIN TIME TESTGJS1994-05-18
299601800289689K940401JR. MICROCOAGULATION SYSTEMJPA1994-05-11
2986901968814310K934053QUANTA LITE(TM) HISTONE ELISALLL1993-12-21
299661179657055K931721IL TEST FIBRINOGEN-CKQJ1993-08-13
1978361179657055K931721IL TEST FIBRINOGEN-CKQJ1993-08-13
3376461179657055K931721IL TEST FIBRINOGEN-CKQJ1993-08-13
2986901844460183K930486QUANTA LITE(TM) THYROID T ELISADDC1993-03-15
2986901046092824K926562QUANTA LITE(TM) JO-1 ELISA KITLLL1993-03-04
2986901311198195K924898QUANTA LITE(TM) SCL-70 ELISALLL1992-12-15
299601220629430K923302TENDERLETT FINGERFMK1993-01-22
2986901420877028K922833QUANTA LITE RNP ELISALLL1992-09-18
2986901333687217K922832QUANTA LITE SS-B ELISALLL1992-09-18
2986901741157067K922831QUANTA LITE SM ELISALLL1992-09-18
2986901848683790K922830QUANTA LITE SS-A ELISALLL1992-09-18
2986902036680537K922829QUANTA LITE ENA ELISALLL1992-09-18
299661115167536K922201COAMATE PROTEIN C CHROMOGENIC ASSAYGGP1992-12-07
3376461115167536K922201COAMATE PROTEIN C CHROMOGENIC ASSAYGGP1992-12-07
299601140661526K922075AVOXIMETERDQA1992-11-04
2986901593626931K922075AVOXIMETERDQA1992-11-04
299601870179862K913861HEMOCHRON(R) KACTJBP1991-10-18
299601819604695K910105PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200GFT1991-02-26
299601560395291K904003HEMOCHRON(R) HEPARIN RESPONSE TESTKFF1990-11-29
2986902063829050K903898QUANTA LITE TM DSDNALLL1990-09-05
2986901702175032K901596NOVA LITE(TM) ANA KSLDHN1990-05-02
299602021461086K882481HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/IIGGN1988-08-30
2986901423144369K881340NOVA LITE(TM) AUTOANTIBODY CONTROLSLLL1988-06-08
2986901298943137K881339NOVA LITE(TM) ANA PLUSLLL1988-04-21
2986901978081314K880742NOVA LITE(TM) DSDNADHN1988-03-25
2986901247354049K880736NOVA LITE(TM) ANALLL1988-03-25
299601509976125K870831PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRAJPA1987-06-01
299661262449478K862301IL SYSTEM 810, ACL AND THE REAGENT SETSGJA1986-09-03
1978361262449478K862301IL SYSTEM 810, ACL AND THE REAGENT SETSGJA1986-09-03
3376461262449478K862301IL SYSTEM 810, ACL AND THE REAGENT SETSGJA1986-09-03
299601279147796K850542SURGICUTT - BLEEDING TIME DEVICEJCA1985-03-01
299661557752371K833891COATEST HEPARINKFF1984-01-30
3376461557752371K833891COATEST HEPARINKFF1984-01-30
299661609737178K823480IL 943 FLAME PHOTOMETERJJO1983-01-09
299601337402994K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLKQJ2025-07-24
299661337402994K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLKQJ2025-07-24
3376461337402994K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLKQJ2025-07-24
299601057043269K243374HemosIL CL HIT-IgG(PF4-H)LCO2025-01-28
3376461057043269K243374HemosIL CL HIT-IgG(PF4-H)LCO2025-01-28
299601538470184K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)GKP2024-08-16
3376461538470184K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)GKP2024-08-16
299601204385345K233790ACL TOP 970 CLJPA2023-12-29
3376461204385345K233790ACL TOP 970 CLJPA2023-12-29
299601097462032K231031ACL TOP Family 70 SeriesGKP2023-06-21
3376461097462032K231031ACL TOP Family 70 SeriesGKP2023-06-21
299601219629958K230852HemosIL Chromogenic Factor IXGGP2023-12-13
299661219629958K230852HemosIL Chromogenic Factor IXGGP2023-12-13

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
GGP352023-12-13
JPA322023-12-29
GJT272018-03-22
GGN232014-08-15
LLL192015-01-29
CHL172023-08-10
CGA162023-01-27
DAP162017-11-22
GJS152022-08-16
KFF142022-10-04
GKP112024-08-16
GFO112016-03-16
MSV102015-12-21
MID102013-02-26
KQJ92025-07-24
MVM92011-03-23
MST82012-09-20
LCO62025-01-28
JOZ62015-07-24
MOB62012-07-31
JGS52019-02-16
JBQ52007-02-23
GGW51996-12-23
QLU42023-06-23
CEM42012-05-03
FMK32023-03-02
GIR32011-08-24
LPS32006-09-22
JIX32004-09-28
DHR31998-11-04
GIS31996-11-29
JBP31996-08-12
GJA31986-09-03
GKF22016-12-14
LJM22014-02-07
NHX22008-03-05
LRM22006-11-21
NRI22006-10-18
JIS22003-06-06
LYR22003-03-27

PMN

200 records. Showing 1-40. Next

GUDID

200 records. Showing 1-40. Next