Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2026994

FEI Number

2026994

Entity Name

INOVA DIAGNOSTICS, INC.

City/State/Country

SAN DIEGO, CA, US

Establishment Address

9900 Old Grove Rd, SAN DIEGO, CA 92131, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INOVA DIAGNOSTICS, INC. (Owner Number: 2026994)

Owner / Operator Contact Address

9900 OLD GROVE RD., --, San Diego, CA 92131, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K123880

PMA Number

N/A

All Registered Proprietary Names

QUANTA Lite Intrinsic Factor ELISA QUANTA Lite dsDNA ELISA QUANTA Lite ds DNA ELISA double stranded DNA ELISA QUANTA Lite HMGCR ELISA PBS Concentrate (40x) PBS II Concentrate (40x) Mounting Medium Pack Mounting Medium FITC IgA Conjugate FITC IgG Conjugate FITC IgG Conjugate Primate Absorbed FITC IgG Conjugate with DAPI FITC IgGAM Conjugate QUANTA Lite SS-A ELISA QUANTA LIte GPA (Gastric Parietal Cell Antibody) ELISA QUANTA Lite GPA ELISA (Gastric Parietal Cell Antibody) QUANTA Lite GPA ELISA QUANTA Lite LKM-1 ELISA Aptiva APS IgA Reagent ANA PCNA Pattern Pemphigus Positive Control Atypical ANCA Positive Pemphigus Positive Mitochondrial (AMA) Pattern Endomysial (Celiac) Positive Smooth Muscle (ASMA) Pattern Gastric Parietal Cell (GPA) Pattern QUANTA Lite HA dsDNA ELISA QUANTA Flash ENA7 Controls QUANTA Flash ENA7 Control Kit QUANTA Flash ENA7 Reagent Kit QUANTA Flash ENA7 Calibrator Kit QUANTA Flash ENA7 Calibrators QUANTA Flash ENA7 Reagents QUANTA Lite SS-A 52 ELISA QUANTA Lite RNA Pol III ELISA QUANTA Lite RNA Pol III NOVA View Automated Fluorescence Microscope with AUTOLoader NOVA View Automated Fluorescence Microscope NOVA View QUATNA Flash SS-B Calibrators QUATNA Flash SSB Controls QUANTA Flash SSB Reagents QUANTA Flash SS-B Controls QUATNA Flash SS-B Reagents QUANTA Flash SSB Calibrators NOVA Lite dsDNA NOVA Lite dsDNA Crithidia luciliae QUANTA LIte Gliadin IgG II ELISA Bulk Pack QUANTA Lite IgG II QUANTA Lite Gliadin IgG II ELISA QUANTA Flash PR3 Calibrators QUANTA Flash PR3 Reagents QUANTA Flash MPO Calibrators QUANTA Flash GBM Calibrators QUANTA Flash MPO Reagents QUANTA Flash MPO QUANTA Flash MPO Controls QUANTA Flash GBM Controls QUANTA Flash GBM QUANTA Flash PR3 Controls QUANTA Flash PR3 QUANTA Flash GBM Reagents QUANTA Lite B2 GPI IgM ELISA QUANTA Lite B2 GPI IgM ELISA Bulk Pack NOVA Lite Rat Liver,Kidney,Stomach NOVA Lite Rat Liver, Kidney, Stomach Kit QUANTA Lite Celiac DGP Screen ELISA QUANTA Lite Celiac DGP Screen QUANTA Lite PR-3 IgG ELISA Fecal Extraction Device QUANTA Lite Jo-1 ELISA QUANTA Lite h-tTG IgG ELISA (Human Tissue Transglutaminase) QUANTA Lite h-tTG IgG ELISA QUANTA Lite h-tTG IgG ELISA Bulk Pack Aptiva Celiac Disease IgA Reagent QUANTA Lite h-tTG IgA ELISA Bulk Pack QUANTA Lite h-tTG IgA ELISA QUANTA Lite h-tTG IgA ELISA (Human Tissue Transglutaminase) QUANTA Flash B2GP1 IgM Reagents QUANTA Flash B2GP1 IgG Reagents QUANTA Flash B2GP1 IgG QUANTA Flash B2GP1 IgM Controls QUANTA Flash B2GP1 IgG Controls QUANTA Flash B2GP1 IgM QUANTA Flash Intrinsic Factor Reagents QUANTA Flash M2 (MIT3) Reagents QUANTA Flash M2 (MIT3) Controls QUANTA Flash M2 (MIT3) Calibrators NOVA Lite DAPI dsDNA Crithidia luciliae Kit NOVA Lite ANCA (Ethanol Fixed) NOVA Lite ANCA Substrate Slide Pack NOVA Lite ANCA Kit NOVA Lite ANCA Anti-neutrophil Cytoplasmic Autoantibody Reagents QUANTA Lite ACA Screen III QUANTA Lite ACA IgM III ELISA Bulk Pack QUANTA Lite ACA IgM III QUANTA Lite RF IgA ELISA QUANTA Lite H. pylori IgA ELISA QUANTA Lite PR3 SC ELISA Bulk Pack QUANTA Lite PR3 SC ELISA QUANTA Flash Sm Controls QUANTA Flash Sm Calibrators QUANTA Flash Sm Reagents QUANTA Flash RNP Reagents QUANTA Flash RNP Controls QUANTA Flash RNP Calibrators QUANTA Lite CCp3.1 IgG/IgA ELISA Bulk Pack QUANTA Lite CCP3.1 IgG/IgA ELISA NOVA Lite ANA KSL NOVA Lite ANA KSL Kit QUANTA Flash Ro52 Reagents QUANTA Flash Ro52 QUANTA Flash Ro52 Controls QUANTA Flash Ro52 Calibrators QUANTA Lite ACA IgG III QUANTA Lite ACA IgG III ELISA Bulk Pack NOVA Lite DAPI ANCA (Formalin) Kit NOVA Lite DAPI ANCA (Ethanol) Kit QUANTA Flash LKM-1 Reagents QUANTA Flash LKM-1 Calibrators QUANTA Flash LKM-1 Controls QUANTA Flash aCL IgA QUANTA Flash B2 GP1 IgA Controls QUANTA Flash aCL IgA Controls QUANTA Flash Cardiolipin IgA Controls QUANTA Flash Cardiolipin IgA QUANTA Flash B2 GP1 IgA Reagents QUANTA Flash aCL IgA Reagents QUANTA Flash B2 GP1 IgA QUANTA Flash Cardiolipin IgA Reagents QUANTA Lite sp100 ELISA QUANTA Lite RNP ELISA QUANTA Lite Actin IgG ELISA QUANTA Lite Actin IgG ELISA Bulk Pack QUANTA Lite Centromere ELISA QUANTA Lite Centromere (CENP-A &CENP-B) QUANTA Lite SS-B ELISA QUANTA Lite ENA 4 ELISA Sm,RNP, SS-A and SS-B Screening Test QUANTA Lite ENA 4 ELISA QUANTA Lite ENA 4 NOVA Lite Autoantibody Controls Auto AB Panel NOVA Lite Auto AB Panel QUANTA Lite Phosphatidylserine IgG 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 IgM ELISA QUANTA Lite Phosphatidylserine IgA ELISA NOVA Lite ANA Plus NOVA Lite ANA Plus Mouse Kidney & Stomach QUANTA Lite dsDNA SC ELISA QUANTA Lite Gliadin IgG ELISA QUANTA Lite Gliadin IgG ELISA Bulk Pack NOVA Lite DAPI ANA Kit QUANTA Flash Ribosomal P Reagents Aptiva APS IgG Reagent Aptiva APS IgM Reagent QUANTA Lite RF IgM ELISA QUANTA Flash CTD Screen Plus Calibrators Aptiva Celiac Disease IgA Calibrators Aptiva Celiac Disease IgG Calibrators Aptiva APS IgM Calibrators Aptiva APS IgG Calibrators Aptiva CTD Essential Calibrators QUANTA Lite ANA ELISA Sm,RNP,SS-A,SS-B,Scl-70 & Jo-1 Screening Test QUANTA Lite ENA 6 ELISA QUANTA Lite RF IgG ELISA F-Actin Slide NOVA Lite IgG F-Actin QUANTA Flash B2GP1-Domain1 QUANTA Flash B2GP1-Domain1 Reagents QUANTA Flash B2GP1-Domain1 Controls HemosIL Acustar Anti-B2GPI-Domain 1 Reagents HemosIL Acustar Anti-B2GPI-Domain 1 Controls HemosIL Acustar Anti-B2GPI-Domain 1 Aptiva System Aptiva Multi-Analyte Instrument Aptiva Optical Cleaning Solution Aptiva Optical Control Kit Aptiva System Rinse Aptiva System Cleaning Solution Kit Instrument System Cuvettes Aptiva Optical Calibrator Kit QUANTA Lite CCP3 IgG ELISA QUANTA Lite CCP3 IgG ELISA Bulk Pack QUANTA Flash dsDNA Reagents QUANTA Flash dsDNA Controls QUANTA Flash dsDNA Calibrators QUANTA Flash dsDNA QUANTA Flash h-tTG IgA QUANTA Flash h-tTG IgA Calibrators QUANTA Flash h-tTG IgA Controls QUANTA Flash h-tTG IgA Reagents Aptiva CTD Essential Reagent QUANTA Lite Scl-70 ELISA QUANTA Lite TPO ELISA NOVA Lite IFA Pancreatic Islet Cell Positive Control NOVA Lite IFA Yo (PCA-1) Positive Control QUANTA Flash RF IgM Controls QUANTA Flash RF IgA Controls QUANTA Flash HMGCR Controls QUANTA Flash Ribosomal P Controls QUANTA Flash DFS70 Controls QUANTA Flash Intrinsic Factor Control Hu (ANNA-1) Positive Control NOVA Lite® IFA Hu (ANNA-1) Positive Control Pancreatic Islet Cell Positive Control Yo (Purkinje Cell) Positive Control NOVA View Automated Fluorescence Microscope NOVA View NOVA View 2 QUANTA Lite MPO IgG ELISA QUANTA Flash RF IgA Reagents QUANTA Flash RF IgM QUANTA Flash RF IgA QUANTA Flash RF IgM Reagents QUANTA Lite Calprotectin Extended Range QUANTA Lite Ribosome P ELISA QUANTA Lite Gliadin IgA II ELISA QUANTA Lite Gliadin IgA II ELISA Bulk Pack QUANTA Lite h-tTG/DGP Screen ELISA QUANTA Lite h-tTG/DGP Screen QUANTA Lite H. pylori IgG ELISA QUANTA Flash CTD Screen Plus Reagents QUANTA Flash Ribosomal P Calibrators QUANTA Flash DFS70 Calibrators QUANTA Flash HMGCR Calibrators QUANTA Flash Intrinsic Factor Calibrators QUANTA Flash RF IgA Calibrators QUANTA Flash RF IgM Calibrators QUANTA Lite ENA 5 ELISA Sm,RNP,SS-A,SS-B and Scl-70 Screening Test QUANTA Lite Sm ELISA QUANTA Flash CCP3 Reagents QUANTA Flash CCP3 Controls QUANTA Flash CCP3 Calibrators QUANTA Flash CCP3 QUANTA Flash h-tTG IgG Calibrators QUANTA Flash h-tTG IgG Reagents QUANTA Flash h-tTG IgG Controls QUANTA Flash h-tTG QUANTA Lite SLA ELISA QUANTA Lite SLA ELISA (Soluble Liver Antigen) QUANTA Lite SLA QUANTA Flash Jo-1 QUANTA Flash Jo-1 Calibrators QUANTA Flash Jo-1 Reagents QUANTA Flash Jo-1 Controls QUANTA Lite R h-tTG IgA ELISA Bulk Pack QUANTA Lite R h-tTG IgA ELISA QUANTA Lite R h-tTG IgG ELISA QUANTA Lite R h-tTG IgG ELISA Bulk Pack QUANTA Flash CTD Screen Plus Controls Aptiva Celiac Disease IgG Controls Aptiva Celiac Disease IgA Controls Aptiva CTD Essential Controls Aptiva APS IgG Controls Aptiva APS IgM Controls Aptiva APS IgA Controls QUANTA Flash aPL Multi Controls QUANTA-Lyser 160 QUANTA-Lyser 2 QUANTA-Lyser 3000 QUANTA-Lyser 240 QUANTA-Lyser ELISA/IFA+Incubator QUANTA-Lyser IFA QUANTA-Lyser ELISA/IFA Aptiva Celiac Disease IgG Reagent QUANTA Flash DGP Screen Reagents QUANTA Flash DGP Screen Calibrators QUANTA Flash DGP Screen Controls QUANTA Flash DGP Screen QUANTA Flash Centromere Calibrators QUANTA Flash Centromere Reagents QUANTA Flash Centromere Controls

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LIG	Radioassay, Intrinsic Factor Blocking Antibody	Clinical Chemistry	Class 2	862.1810	2007-01-22
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2012-08-02
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2013-09-17
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2018-01-30
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2012-08-02
MLE	Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control	Immunology	Class 2	866.5110	2009-01-14
NBS	Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)	Immunology	Class 2	866.5660	2009-01-14
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2026-06-09
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2026-06-09
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2013-09-12
LRM	Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	Immunology	Class 2	866.5100	2012-08-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-05-16
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-05-16
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2013-05-16
OBE	Anti-Ss-A 52 Autoantibodies	Immunology	Class 2	866.5100	2007-04-18
NYO	Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody	Immunology	Class 2	866.5100	2007-05-02
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	Class 2	866.4750	2015-12-02
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-02-17
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2015-02-17
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2015-02-17
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2009-01-26
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2012-08-09
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2012-08-02
MVJ	Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)	Immunology	Class 2	866.5660	2012-08-02
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2012-08-02
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-08-02
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2012-08-09
DBL	Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5660	2012-08-09
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2012-08-09
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2009-01-26
NXO	Calprotectin, Fecal	Immunology	Class 2	866.5180	2018-10-25
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2012-08-02
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2012-08-09
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2021-09-02
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2021-09-02
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2021-09-02
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2012-08-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-11-14
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2011-11-14
LIG	Radioassay, Intrinsic Factor Blocking Antibody	Clinical Chemistry	Class 2	862.1810	2020-10-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2017-09-11
DBM	Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5090	2017-09-11
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-09-11
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	Class 2	866.4750	2021-03-01
KTL	Anti-Dna Indirect Immunofluorescent Solid Phase	Immunology	Class 2	866.5100	2021-03-01
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2012-08-02
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2012-08-09
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2012-08-09
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2012-08-09
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2012-08-09
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2012-08-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-05-01
LKO	Anti-Rnp Antibody, Antigen And Control	Immunology	Class 2	866.5100	2013-05-01
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-05-01
LKP	Anti-Sm Antibody, Antigen And Control	Immunology	Class 2	866.5100	2013-05-01
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Immunology	Class 2	866.5775	2012-08-09
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2012-08-09
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2015-03-17
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2015-03-17
OBE	Anti-Ss-A 52 Autoantibodies	Immunology	Class 2	866.5100	2015-03-17
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2009-01-26
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2017-02-06
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2017-09-06
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2017-09-06
NBS	Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)	Immunology	Class 2	866.5660	2017-09-06
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2013-03-27
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-03-27
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2013-03-27
NUM	Autoantibodies, Nuclear Body Protein, Sp100	Immunology	Class 2	866.5090	2005-08-22
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2012-08-02
NJF	Antibodies, Anti-Actin, Anti-Smooth Muscle	Immunology	Class 2	866.5120	2009-01-14
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2012-08-09
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2012-08-02
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2012-08-02
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2012-08-02
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2012-08-09
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2012-08-02
LRM	Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	Immunology	Class 2	866.5100	2010-01-14
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2012-08-09
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2015-04-13
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	Class 2	866.4750	2015-04-13
MQA	Anti-Ribosomal P Antibodies	Immunology	Class 2	866.5100	2014-04-02
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2025-05-01
MID	System, Test, Anticardiolipin Immunological	Immunology	Class 2	866.5660	2025-05-01
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2009-01-26
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2021-10-22
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2012-08-09
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2012-08-09
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2012-08-09
NJF	Antibodies, Anti-Actin, Anti-Smooth Muscle	Immunology	Class 2	866.5120	2014-02-06
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	Class 2	866.5660	2016-01-22
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	Class 2	862.2570	2020-10-19
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Immunology	Class 2	866.5775	2012-08-09
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2016-04-13
LSW	Anti-Dna Antibody, Antigen And Control	Immunology	Class 2	866.5100	2016-04-13
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-04-13
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2010-12-13
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2010-12-13
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2010-12-13
LKP	Anti-Sm Antibody, Antigen And Control	Immunology	Class 2	866.5100	2023-10-05
MQA	Anti-Ribosomal P Antibodies	Immunology	Class 2	866.5100	2023-10-05
LKO	Anti-Rnp Antibody, Antigen And Control	Immunology	Class 2	866.5100	2023-10-05
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2023-10-05
OBE	Anti-Ss-A 52 Autoantibodies	Immunology	Class 2	866.5100	2023-10-05
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2023-10-05
LSW	Anti-Dna Antibody, Antigen And Control	Immunology	Class 2	866.5100	2023-10-05
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2012-08-02
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2012-08-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2018-08-30
DHN	Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	Immunology	Class 2	866.5100	2015-04-13
PIV	Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	Immunology	Class 2	866.4750	2015-04-13
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	Immunology	Class 2	866.5660	2012-08-09
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2019-04-22
NXO	Calprotectin, Fecal	Immunology	Class 2	866.5180	2020-07-17
MQA	Anti-Ribosomal P Antibodies	Immunology	Class 2	866.5100	2009-01-26
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2012-08-09
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2012-08-09
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2012-08-09
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2009-01-26
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	Class 2	866.5100	2014-05-28
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-08-30
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2012-08-09
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2012-08-02
NHX	Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	Immunology	Class 2	866.5775	2015-09-22
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2012-08-09
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2012-08-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-08-09
NIY	Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis	Immunology	Class 2	866.5660	2009-01-14
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2016-02-16
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2016-02-16
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2016-02-16
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2012-08-09
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2020-03-05
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2011-08-03
MVM	Autoantibodies, Endomysial(Tissue Transglutaminase)	Immunology	Class 2	866.5660	2021-09-02
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2021-09-02
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2011-11-14
MST	Antibodies, Gliadin	Immunology	Class 2	866.5750	2011-11-14
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2011-11-14
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-02-10
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-02-10
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2014-02-10

Official Correspondent

Constance Bridges

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INOVA DIAGNOSTICS, INC.

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K981281	Roche Diagnostics GmbH	ELECSYS CALCHECK FERRITIN	1998-04-24
K981278	Roche Diagnostics GmbH	ELECSYS CALCHECK CA 125II	1998-04-23
K143687	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	2015-07-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2008	Louisville Apl Diagnostics Inc	2	APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).
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-0164-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
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.

Similar Registrations

Registration Number	Establishment Name	Location
3009518015	7051395 CANADA INC DBA HTA DIRECT SOURCING	Champlain, NY, US
2122870	BECKMAN COULTER, INC.	CHASKA, MN, US
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US
3002806944	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED	LLANBERIS Wales, GB
2245285	DRG International, Inc.	Springfield, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2026994. Last updated year: 2026. Please use registration number 2026994 when referencing this establishment in official correspondence.