Data / Medical devices / United States / Inova Diagnostics, Inc.

Inova Diagnostics, Inc.: FDA-registered device maker in San Diego, CA, United States, 112 510(k) clearances

Name: Inova Diagnostics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Inova Diagnostics, Inc. is registered with the FDA (registration 2026994) in San Diego, CA, United States. It lists 46 device types. The FDA files 112 510(k) clearances under its listings, the newest dated February 6, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Inova Diagnostics, Inc.

FDA registration number: 2026994
Address: 9900 Old Grove Rd, San Diego, CA, United States, 92131
Owner or operator: INOVA DIAGNOSTICS, INC. (2026994)
Roles: Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed: August 22, 2005
Registered through: 2026
Brand names listed: (anti-phosphatidylserineand prothombin), ANA KSL (Mouse Kidney, Stomach, Liver) Slide, ANA PCNA Pattern, ANCA (Ethanol Fixed Human Neutrophil) Slide, ANCA (Formalin Fixed Human Neutrophil) Slide, Anti-C1q ELISA Plate, Anti-C1q High Positive, Anti-C1q Low Positive and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer	accessdata.fda.gov
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control	LRM	2	Manufacturer	accessdata.fda.gov
Anti-Dna Antibody, Antigen And Control	LSW	2	Manufacturer	accessdata.fda.gov
Anti-Dna Indirect Immunofluorescent Solid Phase	KTL	2	Manufacturer	accessdata.fda.gov
Anti-Ribosomal P Antibodies	MQA	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Anti-Rnp Antibody, Antigen And Control	LKO	2	Manufacturer	accessdata.fda.gov
Anti-Sm Antibody, Antigen And Control	LKP	2	Manufacturer	accessdata.fda.gov
Anti-Ss-A 52 Autoantibodies	OBE	2	Manufacturer	accessdata.fda.gov
Antibodies, Anti-Actin, Anti-Smooth Muscle	NJF	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)	NHX	2	Manufacturer	accessdata.fda.gov
Antibodies, Gliadin	MST	2	Manufacturer	accessdata.fda.gov
Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)	NBT	2	Manufacturer	accessdata.fda.gov
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control	DBM	2	Manufacturer	accessdata.fda.gov
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	LJM	2	Manufacturer	accessdata.fda.gov
Antinuclear Antibody, Antigen, Control	LKJ	2	Manufacturer for export	accessdata.fda.gov
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control	DHN	2	Manufacturer	accessdata.fda.gov
Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex	OPN	2	Manufacturer	accessdata.fda.gov
Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody	NYO	2	Manufacturer	accessdata.fda.gov
Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis	NIY	2	Manufacturer	accessdata.fda.gov
Autoantibodies, Endomysial(Tissue Transglutaminase)	MVM	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)	NBS	2	Manufacturer	accessdata.fda.gov
Autoantibodies, Nuclear Body Protein, Sp100	NUM	2	Manufacturer	accessdata.fda.gov
Autoantibodies, Nuclear Pore Glycoprotein Gp210	NRI	2	Manufacturer	accessdata.fda.gov
Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use	PIV	2	Manufacturer	accessdata.fda.gov
Calibrator, Multi-Analyte Mixture	JIX	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Manufacturer	accessdata.fda.gov
Calprotectin, Fecal	NXO	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Complement C1q, Antigen, Antiserum, Control	DAK	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)	MVJ	2	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control	MLE	2	Manufacturer	accessdata.fda.gov
Extractable Antinuclear Antibody, Antigen And Control	LLL	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
General Purpose Reagent	PPM	1	Manufacturer	accessdata.fda.gov
Helicobacter Pylori	LYR	1	Manufacturer	accessdata.fda.gov
Instrumentation For Clinical Multiplex Test Systems	NSU	2	Manufacturer, Specification developer	accessdata.fda.gov
Multi-Analyte Controls Unassayed	OHQ	1	Manufacturer	accessdata.fda.gov
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control	DBL	2	Manufacturer	accessdata.fda.gov
Radioassay, Intrinsic Factor Blocking Antibody	LIG	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Reagents, Specific, Analyte	MVU	1	Manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
System, Multipurpose For In Vitro Coagulation Studies	JPA	2	Repackager or relabeler	accessdata.fda.gov
System, Test, Anticardiolipin Immunological	MID	2	Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
System, Test, Rheumatoid Factor	DHR	2	Manufacturer	accessdata.fda.gov
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	MSV	2	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)	MOB	2	Manufacturer	accessdata.fda.gov
Thyroglobulin, Antigen, Antiserum, Control	DDC	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 112.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 6, 2026	K243979	Aptiva APS IgA Reagent	MSV	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
December 17, 2024	K223093	Aptiva APS IgG Reagent; Aptiva APS IgM Reagent	MID	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
September 29, 2023	K213403	Aptiva CTD Essential Reagent	LLL	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
August 26, 2021	K200230	Aptiva Celiac Disease IgG Reagent	MVM	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
June 16, 2021	K193604	Aptiva Celiac Disease IgA Reagent	MVM	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
December 11, 2020	K192916	NOVA Lite DAPI dsDNA Crithidia luciliae Kit	KTL	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
July 10, 2019	K191592	CalprestNG, EasyCal	NXO	Substantially Equivalent	Eurospital S.P.A.	accessdata.fda.gov
April 17, 2019	K190088	QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents	DHR	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
October 16, 2018	K180971	QUANTA Flash Calprotectin and Fecal Extraction Device	NXO	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
June 25, 2018	K180975	QUANTA Flash HMGCR Reagents	LLL	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
December 22, 2017	K170993	QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer	NXO	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
September 6, 2017	K163538	QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls	NBS	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
September 5, 2017	K163525	QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls	DBM	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
March 3, 2017	K170314	ACL AcuStar	JPA	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
February 3, 2017	K161258	NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit	MOB	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
June 1, 2016	K152635	QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls	LLL	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
April 11, 2016	K152013	QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls	LSW	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
February 12, 2016	K151429	QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols	LLL	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
December 21, 2015	K152875	QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls	MSV	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
November 24, 2015	K153150	AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000	PIV	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
September 21, 2015	K143754	QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3	NHX	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
April 9, 2015	DEN140039	NOVA View Automated Fluorescense Microscope	PIV	Unknown	Inova Diagnostics, Inc.	accessdata.fda.gov
April 8, 2015	K150155	NOVA Lite DAPI ANA Kit	DHN	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
March 5, 2015	K141655	QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS	OBE	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
February 12, 2015	K141328	QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS	LLL	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
January 29, 2015	K141210	QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS	LLL	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
February 7, 2014	K123880	QUANTA FLASH CENTROMERE	LJM	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
May 7, 2013	K122923	QUANTA FLASH ENA7	LLL	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
April 17, 2013	K123593	QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,	LKP	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
February 26, 2013	K120817	QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA	MID	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
September 20, 2012	K113863	QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS	MST	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
July 31, 2012	K112545	QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM	MOB	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
October 20, 2011	K111414	QUANTA FLASH (TM) DGP SCREEN	MST	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
March 23, 2011	K101644	QUANTA FLASH H-TTG IGG	MVM	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
October 13, 2010	K094060	QUANTA FLASH H-TTG IGA	MVM	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
May 21, 2010	K091556	HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS	MSV	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
March 11, 2010	K092181	HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS	MID	Substantially Equivalent	Instrumentation Laboratory CO	accessdata.fda.gov
February 1, 2010	K090755	QUANTA LITE APS/PT IGG AND IGM ELISA	OPN	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
March 5, 2008	K072944	QUANTA LITE CCP3.1 IGG/IGA ELISA	NHX	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
February 12, 2008	K073145	QUANTA LITE H-TTG SCREEN	MVM	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
January 28, 2008	K072967	QUANTA LITE F-ACTIN IGA ELISA	MVM	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
April 11, 2007	K070066	QUANTA LITE RNA POL III ELISA	NYO	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
April 4, 2007	K063565	QUANTA LITE SS-A 52 ELISA	OBE	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
March 12, 2007	K070083	QUANTA LITE H-TTG/DGP SCREEN	MST	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
December 22, 2006	K061841	QUANTA LITE INTRINSIC FACTOR ELISA	LIG	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
December 13, 2006	K062708	QUANTA LITE CELIAC DGP SCREEN	MST	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
November 21, 2006	K062183	FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT	LRM	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
October 18, 2006	K061842	QUANTA LITE PBC SCREEN IGG/IGA ELISA	NRI	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
November 23, 2005	K052264	QUANTA LITE CCP3 IGG ELISA	NHX	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
October 27, 2005	K052262	QUANTA LITE M2 EP (MIT3) ELISA	DBM	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
October 4, 2005	K052143	QUANTA LITE GLIADIN IGA II	MST	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
October 4, 2005	K052142	QUANTA LITE GLIADIN IGG II	MST	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
June 13, 2005	K050662	QUANTA LITE SP100 ELISA	NUM	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
July 16, 2004	K040466	BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITS	MVM	Substantially Equivalent	The Binding Site	accessdata.fda.gov
June 25, 2004	K040885	QUANTA LITE GP210 ELISA	NRI	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
September 29, 2003	K032240	BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT	MID	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
September 10, 2003	K031563	BINDAZYME CLQ CIC EIA KIT	DAK	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
March 27, 2003	K024334	QUANTA LITE H.PYLORI IGA ELISA	LYR	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
September 20, 2002	K021648	QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA	NJF	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
July 30, 2002	K021482	QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA	NIY	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
July 9, 2001	K011570	QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA	MVM	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
July 9, 2001	K011566	QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA	MVM	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
May 21, 2001	K000733	QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA	NBT	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
April 3, 2001	K010558	QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA	MLE	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
January 22, 2001	K003959	QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA	LJM	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
August 16, 2000	DEN000007	QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA	NBT	Unknown	Inova Diagnostics, Inc.	accessdata.fda.gov
June 7, 2000	K000535	QUANTA LITE LKM-1 ELISA	NBS	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
December 21, 1999	K993727	BINDAZYME ANTI-DSDNA EIA KIT	LRM	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
June 17, 1999	K991657	QUANTA LITE ANA ELISA	LLL	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
February 8, 1999	K984336	QUANTA LITE GBM ELISA	MVJ	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
November 4, 1998	K983084	QUANTA LITE RF IGA ELISA	DHR	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
November 4, 1998	K983083	QUANTA LITE RF IGG ELISA	DHR	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
November 4, 1998	K982790	QUANTA LITE H. PYLORI IGG ELISA	LYR	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
October 22, 1998	K981209	MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITS	MVM	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
October 7, 1998	K982603	QUANTA LITE CHROMATIN ELISA	LLL	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
August 27, 1998	K982366	QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA	MVM	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
July 29, 1998	K981857	QUANTA LITE TPO ELISA	LLL	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
July 20, 1998	K981029	BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT	MOB	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
June 19, 1998	K981330	QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT	MOB	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
June 19, 1998	K981328	QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT	MOB	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
June 5, 1998	K981237	QUANTA LITE RIBOSOME P ELISA	MQA	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
March 24, 1998	K980230	QUANTA LITE B2 GPI SCREEN	MSV	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
October 20, 1997	K973014	QUANTA LITE B2GPI IGM	MSV	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
October 20, 1997	K973006	QUANTA LITE B2 GPI IGA	MSV	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
June 24, 1997	K970551	QUANTA LITE B2GPI IGG	MSV	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
June 20, 1997	K971614	QUANTA LITE RF IGM	DHR	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
June 2, 1997	K964986	QUANTA LITE IGA GLIADIN ELISA	MST	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
May 30, 1997	K964985	QUANTA LITE IGG GLIADIN ELISA	MST	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
May 21, 1997	K965133	ANCA COMBI DIAGNOSTIC TEST KIT	MOB	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
July 10, 1996	K961913	QUANTA LITE ENA 6 ELISA	LLL	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
July 10, 1996	K961340	NOVA LITE ANCA	MOB	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
April 23, 1996	K955431	RIT LIVER, KIDNEY, STOMACH IFA KIT	DBL	Substantially Equivalent	The Binding Site, Ltd.	accessdata.fda.gov
September 1, 1995	K953366	QUANTA LITE IGA ACA (HRP)	MID	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
August 29, 1995	K953291	QUANTA LITE ACA SCREEN (HRP)	MID	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
July 18, 1995	K946385	QUANTA LITE ACA IGM (HRP)	MID	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
July 18, 1995	K946034	QUANTA LITE(TM) IGG (HRP)	MID	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
October 25, 1994	K943076	QUANTA LITE ENA 5 ELISA KIT	LLL	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
December 21, 1993	K934053	QUANTA LITE(TM) HISTONE ELISA	LLL	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
March 15, 1993	K930486	QUANTA LITE(TM) THYROID T ELISA	DDC	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov
March 4, 1993	K926562	QUANTA LITE(TM) JO-1 ELISA KIT	LLL	Substantially Equivalent	Inova Diagnostics, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
January 26, 2018	79380	Class II	Terminated	QUANTA-Lyser 240 IFA, Part #GS0242. The instrument is a fully automated, high-throughput, bench top system designed for clinical use to automate slide and reagent barcode reading, sample dilution and distribution, reagen	The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument.	accessdata.fda.gov
September 26, 2011	60219	Not yet classified	Terminated	Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic.	The NOVA Lite ANA KSL kit label has the wrong fill volume for the IFA System Negative Control (P/N 508186) with 1mL. The component in the kit is correctly labeled and filled with the 0.5mL fill volume.	accessdata.fda.gov
October 28, 2009	55801	Not yet classified	Terminated	Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021	The recall was initiated after the binding site notified Inova Diagnostics, inc. that the affected Bindazyme Human C1q binding Circulating Immune Complex EIA Kits may contain an ELISA plate labeled as "tissue Transglutaminase Coated Wells" instead of "C1q Coated Wells".	accessdata.fda.gov

Compare with other makers

Updated February 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.