Company · US
Inova Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2026. Name variants (Inc, Corp, punctuation) are merged.
138510(k) clearances (1 in 12 months)
4recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 37 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 12 |
| MID | System, Test, Anticardiolipin Immunological | 9 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 8 |
| MST | Antibodies, Gliadin | 8 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 7 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 5 |
| DHR | System, Test, Rheumatoid Factor | 4 |
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | 4 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 3 |
| LSR | Reagent, Borrelia Serological Reagent | 3 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 2 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 2 |
| JZO | System, Test, Thyroid Autoantibody | 2 |
| LYR | Helicobacter Pylori | 2 |
| NBS | Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) | 2 |
| NBT | Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae) | 2 |
| NRI | Autoantibodies, Nuclear Pore Glycoprotein Gp210 | 2 |
| NXO | Calprotectin, Fecal | 2 |
| OBE | Anti-Ss-A 52 Autoantibodies | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 6, 2026 | K243979 | Aptiva APS IgA Reagent Inova Diagnostics, Inc. | MSV |
| Dec 17, 2024 | K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent Inova Diagnostics, Inc. | MID |
| Sep 29, 2023 | K213403 | Aptiva CTD Essential Reagent Inova Diagnostics, Inc. | LLL |
| Aug 26, 2021 | K200230 | Aptiva Celiac Disease IgG Reagent Inova Diagnostics, Inc. | MVM |
| Jun 16, 2021 | K193604 | Aptiva Celiac Disease IgA Reagent Inova Diagnostics, Inc. | MVM |
| Dec 11, 2020 | K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit Inova Diagnostics, Inc. | KTL |
| Apr 17, 2019 | K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents Inova Diagnostics, Inc. | DHR |
| Oct 16, 2018 | K180971 | QUANTA Flash Calprotectin and Fecal Extraction Device Inova Diagnostics, Inc. | NXO |
| Jun 25, 2018 | K180975 | QUANTA Flash HMGCR Reagents Inova Diagnostics, Inc. | LLL |
| Dec 22, 2017 | K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Fl Inova Diagnostics, Inc. | NXO |
| Sep 6, 2017 | K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls Inova Diagnostics, Inc. | NBS |
| Sep 5, 2017 | K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls Inova Diagnostics, Inc. | DBM |
| Feb 3, 2017 | K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit Inova Diagnostics, Inc. | MOB |
| Jun 1, 2016 | K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls Inova Diagnostics, Inc. | LLL |
| Apr 11, 2016 | K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls Inova Diagnostics, Inc. | LSW |
| Feb 12, 2016 | K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols Inova Diagnostics, Inc. | LLL |
| Dec 21, 2015 | K152875 | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar An Inova Diagnostics, Inc. | MSV |
| Nov 24, 2015 | K153150 | AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 Inova Diagnostics, Inc. | PIV |
| Sep 21, 2015 | K143754 | QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 Inova Diagnostics, Inc. | NHX |
| Apr 9, 2015 | DEN140039 | NOVA View Automated Fluorescense Microscope Inova Diagnostics, Inc. | PIV |
| Apr 8, 2015 | K150155 | NOVA Lite DAPI ANA Kit Inova Diagnostics, Inc. | DHN |
| Mar 5, 2015 | K141655 | QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS Inova Diagnostics, Inc. | OBE |
| Feb 13, 2015 | K141274 | QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS. Inova Diagnostics, Inc. | MSV |
| Feb 12, 2015 | K141328 | QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS Inova Diagnostics, Inc. | LLL |
| Jan 29, 2015 | K141210 | QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS Inova Diagnostics, Inc. | LLL |
| Feb 7, 2014 | K123880 | QUANTA FLASH CENTROMERE Inova Diagnostics, Inc. | LJM |
| May 7, 2013 | K122923 | QUANTA FLASH ENA7 Inova Diagnostics, Inc. | LLL |
| Apr 17, 2013 | K123593 | QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, Inova Diagnostics, Inc. | LKP |
| Feb 26, 2013 | K120817 | QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA Inova Diagnostics, Inc. | MID |
| Sep 20, 2012 | K113863 | QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS Inova Diagnostics, Inc. | MST |
| Jul 31, 2012 | K112545 | QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM Inova Diagnostics, Inc. | MOB |
| Oct 20, 2011 | K111414 | QUANTA FLASH (TM) DGP SCREEN Inova Diagnostics, Inc. | MST |
| Mar 23, 2011 | K101644 | QUANTA FLASH H-TTG IGG Inova Diagnostics, Inc. | MVM |
| Oct 13, 2010 | K094060 | QUANTA FLASH H-TTG IGA Inova Diagnostics, Inc. | MVM |
| Feb 1, 2010 | K090755 | QUANTA LITE APS/PT IGG AND IGM ELISA Inova Diagnostics, Inc. | OPN |
| Oct 27, 2008 | K081248 | QUANTA LITE OMP PLUS ELISA Inova Diagnostics, Inc. | OKM |
| Mar 5, 2008 | K072944 | QUANTA LITE CCP3.1 IGG/IGA ELISA Inova Diagnostics, Inc. | NHX |
| Feb 12, 2008 | K073145 | QUANTA LITE H-TTG SCREEN Inova Diagnostics, Inc. | MVM |
| Feb 11, 2008 | K072632 | QUANTA PLEX CELIAC IGG PROFILE Inova Diagnostics, Inc. | MVM |
| Jan 28, 2008 | K072967 | QUANTA LITE F-ACTIN IGA ELISA Inova Diagnostics, Inc. | MVM |
| Jun 20, 2007 | K063818 | QUANTA PLEX CELIAC IGA PROFILE Inova Diagnostics, Inc. | MVM |
| Apr 11, 2007 | K070066 | QUANTA LITE RNA POL III ELISA Inova Diagnostics, Inc. | NYO |
| Apr 4, 2007 | K063565 | QUANTA LITE SS-A 52 ELISA Inova Diagnostics, Inc. | OBE |
| Mar 12, 2007 | K070083 | QUANTA LITE H-TTG/DGP SCREEN Inova Diagnostics, Inc. | MST |
| Dec 22, 2006 | K061841 | QUANTA LITE INTRINSIC FACTOR ELISA Inova Diagnostics, Inc. | LIG |
| Dec 13, 2006 | K062708 | QUANTA LITE CELIAC DGP SCREEN Inova Diagnostics, Inc. | MST |
| Oct 18, 2006 | K061842 | QUANTA LITE PBC SCREEN IGG/IGA ELISA Inova Diagnostics, Inc. | NRI |
| Nov 23, 2005 | K052264 | QUANTA LITE CCP3 IGG ELISA Inova Diagnostics, Inc. | NHX |
| Oct 27, 2005 | K052262 | QUANTA LITE M2 EP (MIT3) ELISA Inova Diagnostics, Inc. | DBM |
| Oct 4, 2005 | K052143 | QUANTA LITE GLIADIN IGA II Inova Diagnostics, Inc. | MST |
Newest 50 of 138.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2018 | Inova Diagnostics Incorporated QUANTA-Lyser 240 EIA, Part #GS0241.
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 Terminated |
JJE | None listed |
| Jan 26, 2018 | Inova Diagnostics Incorporated 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 Terminated |
JJE | None listed |
| Nov 23, 2011 | Inova Diagnostics Incorporated Inova Diagnostic Inc., NOVA Lite ANA KSL Kit
Part Number: 708390. in vitro diagnostic. Terminated |
DHN | K901596 |
| Jun 30, 2010 | Inova Diagnostics Incorporated Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021 Terminated |
DAK | K031563 |