Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012348571

FEI Number

3012348571

Entity Name

INSTRUMENTATION LABORATORY SPA

City/State/Country

Roncello Lombardy, IT

Establishment Address

Via Leonardo da Vinci, 36, Roncello Lombardy 20877, IT

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Instrumentation Laboratory SpA (Owner Number: 10082968)

Owner / Operator Contact Address

Viale Monza 338, Milan, IT-25 20128, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K021648

PMA Number

N/A

All Registered Proprietary Names

QUANTA Lite M2 EP (MIT3) ELISA QUANTA Lite M2 EP (MIT3) ELISA Bulk Pack QUANTA Lite M2 EP (MIT3) NOVA Lite Rat Liver,Kidney,Stomach NOVA Lite Rat Liver, Kidney, Stomach Kit QUANTA Flash Jo-1 Reagents QUANTA Flash Jo-1 Controls QUANTA Flash Jo-1 QUANTA Flash Jo-1 Calibrators Auto AB Panel NOVA Lite Autoantibody Controls NOVA Lite Auto AB Panel QUANTA Lite PR3 SC ELISA QUANTA Lite PR3 SC ELISA Bulk Pack QUANTA Flash h-tTG IgA Calibrators QUANTA Flash h-tTG IgA Reagents QUANTA Flash h-tTG IgA Controls QUANTA Flash h-tTG IgA QUANTA Lite ACA IgA III QUANTA Lite ACA IgA ELISA Bulk Pack Aptiva System Rinse Aptiva System Cleaning Solution kit QUANTA Lite F-Actin IgA ELISA QUANTA Lite ANA ELISA NOVA Lite ANA KSL NOVA Lite ANA KSL Kit QUANTA Lite B2 GPI IgA ELISA Bulk Pack QUANTA Lite B2 GPI IgA ELISA QUANTA Lite ENA 5 ELISA Sm,RNP,SS-A,SS-B and Scl-70 Screening Test QUANTA Lite PR-3 IgG ELISA QUANTA Flash CCP3 Reagents QUANTA Flash CCP3 Controls QUANTA Flash CCP3 QUANTA Flash CCP3 Calibrators fib-tem ex-tem ap-tem QUANTA Lite CCp3.1 IgG/IgA ELISA Bulk Pack QUANTA Lite CCP3.1 IgG/IgA ELISA QUANTA Lite PBC Screen IgG/IgA ELISA QUANTA Lite B2 GPI Screening ELISA Bulk Pack QUANTA Lite B2 GPI Screening ELISA QUANTA Lite ds DNA ELISA double stranded DNA ELISA QUANTA Lite dsDNA ELISA QUANTA Flash ENA7 Reagent Kit QUANTA Flash ENA7 Calibrator Kit QUANTA Flash ENA7 Calibrators QUANTA Flash ENA7 Controls QUANTA Flash ENA7 Reagents QUANTA Flash ENA7 Control Kit QUANTA Lite Phosphatidylserine IgM ELISA QUANTA Lite Phosphatidylserine IgA ELISA QUANTA Lite Phosphatidylserine IgM ELISA Bulk Pack QUATNA Lite Phosphatidylserine IgM ELISA Bulk Pack QUANTA Lite Phosphatidylserine IgG ELISA Bulk Pack QUANTA Lite Phosphatidylserine IgG ELISA QUANTA Lite Sm ELISA QUANTA LIte GPA (Gastric Parietal Cell Antibody) ELISA QUANTA Lite GPA ELISA (Gastric Parietal Cell Antibody) QUANTA Lite GPA ELISA QUANTA Lite H. pylori IgA ELISA NOVA Lite Monkey Oesophagus IFA Kit QUANTA Lite Celiac DGP Screen QUANTA Lite Celiac DGP Screen ELISA QUANTA Lite ACA IgG III ELISA Bulk Pack QUANTA Lite ACA IgG III QUANTA Flash B2 GP1 IgA Reagents QUANTA Flash Cardiolipin IgA QUANTA Flash Cardiolipin IgA Reagents QUANTA Flash Cardiolipin IgA Controls QUANTA Flash B2 GP1 IgA Controls QUANTA Flash aCL IgA Controls QUANTA Flash B2 GP1 IgA QUANTA Flash aCL IgA Reagents QUANTA Flash aCL IgA NOVA Lite HEp-2 ANA Kit QUANTA Flash Ro60 Calibrators QUANTA Flash Ro60 Controls QUANTA Flash Ro60 Reagents QUANTA Lite H. pylori IgG ELISA QUANTA Lite B2GP1 IgG ELISA Bulk Pack QUANTA Lite B2GPI IgG ELISA QUANTA Lite CCP3 IgG ELISA Bulk Pack QUANTA Lite CCP3 IgG ELISA NOVA Lite ANCA (Formalin Fixed) Anti-neutrophil Cytoplasmic Autoantibody Reagents NOVA Lite ANCA Substrate Slide Pack NOVA Lite ANCA (Formalin) Kit with DAPI NOVA Lite ANCA Formalin Kit QUANTA Flash Centromere Calibrators QUANTA Flash Centromere Reagents QUANTA Flash Centromere Controls QUANTA Lite Gliadin IgG ELISA Bulk Pack QUANTA Lite Gliadin IgG ELISA QUANTA Lite LKM-1 ELISA QUANTA Flash h-tTG QUANTA Flash h-tTG IgG Calibrators QUANTA Flash h-tTG IgG Controls QUANTA Flash h-tTG IgG Reagents QUANTA Lite tTG ELISA QUANTA Lite tTG ELISA (TissueTransglutaminase) NOVA Lite DAPI ANA Kit NOVA View Automated Fluorescence Microscope with AUTOLoader NOVA View NOVA View Automated Fluorescence Microscope QUANTA Lite ASCA IgA ELISA (S. cerevisiae) QUANTA LIte ASCA (S. cerevisiae) IgA QUANTA Lite ASCA IgA ELISA QUANTA Lite B2 GPI IgM ELISA Bulk Pack QUANTA Lite B2 GPI IgM ELISA QUANTA Lite Histone ELISA QUANTA Lite RF IgA ELISA QUANTA Lite Chromatin ELISA QUANTA Lite Ribosome P ELISA QUANTA Lite IgG II QUANTA LIte Gliadin IgG II ELISA Bulk Pack QUANTA Lite Gliadin IgG II ELISA QUANTA Lite Gliadin IgA ELISA QUANTA Lite Gliadin IgA ELISA Bulk Pack QUANTA Lite ENA 4 QUANTA Lite ENA 4 ELISA QUANTA Lite ENA 4 ELISA Sm,RNP, SS-A and SS-B Screening Test QUANTA Lite SLA QUANTA Lite SLA ELISA QUANTA Lite SLA ELISA (Soluble Liver Antigen) QUANTA Lite dsDNA SC ELISA QUANTA Flash Ro52 Controls QUANTA Flash Ro52 Calibrators QUANTA Flash Ro52 Reagents QUANTA Flash Ro52 QUANTA Flash GBM Controls QUANTA Flash GBM Reagents QUANTA Flash GBM Calibrators QUANTA Flash MPO Calibrators QUANTA Flash MPO Reagents QUANTA Flash PR3 Calibrators QUANTA Flash PR3 QUANTA Flash GBM QUANTA Flash MPO QUANTA Flash MPO Controls QUANTA Flash PR3 Reagents QUANTA Flash PR3 Controls BIO-FLASH System Rinse HemosIL Acustar System Rinse QUANTA Lite RF IgG ELISA QUANTA Lite h-tTG/DGP Screen QUANTA Lite h-tTG/DGP Screen ELISA QUANTA Lite SS-A ELISA HemosIL AcuStar Anti-Cardiolipin IgM Controls HemosIL AcuStar Anti-Cardiolipin IgG HemosIL AcuStar Anti-Cardiolipin IgG Controls HemosIL AcuStar Anti-Cardiolipin IgM QUANTA Flash aCL IgG QUANTA Flash aCL IgM QUANTA Flash aCL IgG Reagents QUANTA Flash aCL IgM Reagents QUANTA Flash aCL IgM Controls QUANTA Flash aCL IgG Controls QUANTA Lite HA dsDNA ELISA QUANTA Lite RF IgM ELISA NOVA Lite ANA Plus NOVA Lite ANA Plus Mouse Kidney & Stomach QUANTA Lite h-tTG IgA ELISA Bulk Pack QUANTA Lite h-tTG IgA ELISA QUANTA Flash Sm Controls QUANTA Flash RNP Reagents QUANTA Flash RNP Calibrators QUANTA Flash Sm Reagents QUANTA Flash Sm Calibrators QUANTA Flash RNP Controls QUANTA Lite Jo-1 ELISA QUANTA Flash SSB Reagents QUANTA Flash SSB Calibrators QUATNA Flash SS-B Reagents QUATNA Flash SSB Controls QUANTA Flash SS-B Controls QUATNA Flash SS-B Calibrators QUANTA Lite Actin IgG ELISA QUANTA Lite Actin IgG ELISA Bulk Pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DBM	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5090	2024-11-20
DBL	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5660	2024-12-05
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2026-06-19
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2026-06-19
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2026-06-19
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2024-11-21
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2024-12-05
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2024-11-20
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-11-20
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2024-11-20
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2024-11-28
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2021-10-18
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2024-11-20
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2024-12-05
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2024-11-25
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2024-11-28
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2024-11-25
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2024-11-20
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Immunology	Class 2	866.5775	2026-06-05
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2021-11-16
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Immunology	Class 2	866.5775	2024-12-05
DBM	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5090	2024-12-05
NRI	Autoantibodies, Nuclear Pore Glycoprotein Gp210	Immunology	Class 2	866.5090	2024-12-05
NUM	Autoantibodies, Nuclear Body Protein, Sp100	Immunology	Class 2	866.5090	2024-12-05
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2024-11-20
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2024-11-21
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2024-12-05
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-12-05
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2024-12-05
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2024-12-05
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2024-11-25
MLE	Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control	Immunology	Class 2	866.5110	2024-11-20
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2024-11-28
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2024-12-05
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2024-12-05
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2024-11-20
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2023-12-01
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2023-12-01
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2023-12-01
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2024-11-21
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2026-06-05
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2026-06-05
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2026-06-05
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2024-11-20
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2024-11-28
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Immunology	Class 2	866.5775	2024-12-05
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2024-11-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2026-04-27
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2026-04-27
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2026-04-27
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2024-11-28
NBS	Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)	Immunology	Class 2	866.5660	2024-11-20
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-12-05
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2024-12-05
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2024-12-05
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2024-12-05
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	Class 2	866.4750	2026-06-05
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2026-06-05
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	Class 2	866.4750	2026-06-05
NBT	Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)	Immunology	Class 2	866.5785	2024-12-05
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2024-11-28
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2024-11-21
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2024-11-28
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2024-11-28
MQA	Anti-Ribosomal P Antibodies	Immunology	Class 2	866.5100	2024-11-20
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2024-12-05
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2024-11-28
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2024-11-22
NIY	Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis	Immunology	Class 2	866.5660	2024-11-20
LRM	Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	Immunology	Class 2	866.5100	2024-11-20
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2026-06-05
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2026-06-05
OBE	Anti-Ss-A 52 Autoantibodies	Immunology	Class 2	866.5100	2026-06-05
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2024-11-21
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2024-11-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-11-21
MVJ	Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)	Immunology	Class 2	866.5660	2024-11-21
JPA	System, Multipurpose For In Vitro Coagulation Studies	Hematology	Class 2	864.5425	2024-11-25
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2024-11-28
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2024-12-05
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2024-12-05
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2024-11-25
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2021-11-11
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2021-11-11
LRM	Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	Immunology	Class 2	866.5100	2024-12-05
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2024-11-20
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2024-11-21
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2024-12-05
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2024-12-05
LKP	Anti-Sm Antibody, Antigen And Control	Immunology	Class 2	866.5100	2024-12-05
LKO	Anti-Rnp Antibody, Antigen And Control	Immunology	Class 2	866.5100	2024-12-05
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2024-12-05
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2024-11-25
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2026-05-29
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2026-05-29
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2026-05-29
NJF	Antibodies, Anti-Actin, Anti-Smooth Muscle	Immunology	Class 2	866.5120	2024-11-20

Official Correspondent

Natale Bova

US Agent Details

Carol Marble Email: cmarble@werfen.com Phone: (800) 9559525

Related Public Records

Same Entity

Instrumentation Laboratory SpA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007719797	Instrumentation Laboratory SpA	Ascoli Piceno Marche, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K820088	Calbiochem-Behring Corp.	AFT SYSTEM PROFICIENCY TESTING PROGRAM	1982-01-26
K103744	Quantimetrix Corp.	DROPPER A1C DIABETES CONTROL	2011-05-12
K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
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Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2008	Tosoh Bioscience Inc	1	4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012348571. Last updated year: 2026. Please use registration number 3012348571 when referencing this establishment in official correspondence.