FDA 510(k) Applications Submitted by INOVA DIAGNOSTICS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200230 |
01/30/2020 |
Aptiva Celiac Disease IgG Reagent |
Inova Diagnostics, Inc. |
| K213403 |
10/18/2021 |
Aptiva CTD Essential Reagent |
Inova Diagnostics, Inc. |
| K123880 |
12/17/2012 |
QUANTA FLASH CENTROMERE |
INOVA DIAGNOSTICS, INC. |
| K193604 |
12/23/2019 |
Aptiva Celiac Disease IgA Reagent |
Inova Diagnostics, Inc. |
| K003959 |
12/21/2000 |
QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA |
INOVA DIAGNOSTICS, INC. |
| K070066 |
01/08/2007 |
QUANTA LITE RNA POL III ELISA |
INOVA DIAGNOSTICS, INC. |
| K070083 |
01/09/2007 |
QUANTA LITE H-TTG/DGP SCREEN |
INOVA DIAGNOSTICS, INC. |
| K980230 |
01/22/1998 |
QUANTA LITE B2 GPI SCREEN |
INOVA DIAGNOSTICS, INC. |
| K040160 |
01/23/2004 |
QUANTA PLEX SLE PROFILE 8 |
INOVA DIAGNOSTICS, INC. |
| K980312 |
01/27/1998 |
NOVA LITE ENDOMYSIAL |
INOVA DIAGNOSTICS, INC. |
| K020414 |
02/07/2002 |
QUANTA LITE CCP ELISA |
INOVA DIAGNOSTICS, INC. |
| K970551 |
02/12/1997 |
QUANTA LITE B2GPI IGG |
INOVA DIAGNOSTICS, INC. |
| K010558 |
02/26/2001 |
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA |
INOVA DIAGNOSTICS, INC. |
| K030681 |
03/05/2003 |
QUANTA PLEX ENA PROFILE 5 |
INOVA DIAGNOSTICS, INC. |
| K000733 |
03/06/2000 |
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA |
INOVA DIAGNOSTICS, INC. |
| K050715 |
03/18/2005 |
QUANTA PLEX ANCA PROFILE |
INOVA DIAGNOSTICS, INC. |
| K961340 |
03/25/1996 |
NOVA LITE ANCA |
INOVA DIAGNOSTICS, INC. |
| K981237 |
04/03/1998 |
QUANTA LITE RIBOSOME P ELISA |
INOVA DIAGNOSTICS, INC. |
| K971304 |
04/08/1997 |
QUANTA LITE REBELLA IGG |
INOVA DIAGNOSTICS, INC. |
| K971335 |
04/10/1997 |
QUANTA LITE CMV IGG ELISA |
INOVA DIAGNOSTICS, INC. |
| K981330 |
04/13/1998 |
QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT |
INOVA DIAGNOSTICS, INC. |
| K981328 |
04/13/1998 |
QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT |
INOVA DIAGNOSTICS, INC. |
| K011140 |
04/13/2001 |
QUANTA PLEX ENA PROFILE 4 |
INOVA DIAGNOSTICS, INC. |
| K971441 |
04/18/1997 |
QUANTA LITE TOXOPLASMA IGG |
INOVA DIAGNOSTICS, INC. |
| K971620 |
05/01/1997 |
QUANTA LITE RUBEOLA (MEASLES) IGG |
INOVA DIAGNOSTICS, INC. |
| K971614 |
05/02/1997 |
QUANTA LITE RF IGM |
INOVA DIAGNOSTICS, INC. |
| K031450 |
05/07/2003 |
QUANTA PLEX ENA PROFILE 6 |
INOVA DIAGNOSTICS, INC. |
| K021482 |
05/08/2002 |
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA |
INOVA DIAGNOSTICS, INC. |
| K991657 |
05/13/1999 |
QUANTA LITE ANA ELISA |
INOVA DIAGNOSTICS, INC. |
| K961913 |
05/17/1996 |
QUANTA LITE ENA 6 ELISA |
INOVA DIAGNOSTICS, INC. |
| K021648 |
05/20/2002 |
QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA |
INOVA DIAGNOSTICS, INC. |
| K011570 |
05/21/2001 |
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA |
INOVA DIAGNOSTICS, INC. |
| K011566 |
05/21/2001 |
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA |
INOVA DIAGNOSTICS, INC. |
| K981857 |
05/27/1998 |
QUANTA LITE TPO ELISA |
INOVA DIAGNOSTICS, INC. |
| K982023 |
06/09/1998 |
PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT |
INOVA DIAGNOSTICS, INC. |
| K982366 |
07/07/1998 |
QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA |
INOVA DIAGNOSTICS, INC. |
| DEN000007 |
07/18/2000 |
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA |
INOVA DIAGNOSTICS, INC. |
| K982603 |
07/27/1998 |
QUANTA LITE CHROMATIN ELISA |
INOVA DIAGNOSTICS, INC. |
| K052142 |
08/08/2005 |
QUANTA LITE GLIADIN IGG II |
INOVA DIAGNOSTICS, INC. |
| K052143 |
08/08/2005 |
QUANTA LITE GLIADIN IGA II |
INOVA DIAGNOSTICS, INC. |
| K982790 |
08/10/1998 |
QUANTA LITE H. PYLORI IGG ELISA |
INOVA DIAGNOSTICS, INC. |
| K973014 |
08/13/1997 |
QUANTA LITE B2GPI IGM |
INOVA DIAGNOSTICS, INC. |
| K973006 |
08/13/1997 |
QUANTA LITE B2 GPI IGA |
INOVA DIAGNOSTICS, INC. |
| K052264 |
08/19/2005 |
QUANTA LITE CCP3 IGG ELISA |
INOVA DIAGNOSTICS, INC. |
| K052262 |
08/19/2005 |
QUANTA LITE M2 EP (MIT3) ELISA |
INOVA DIAGNOSTICS, INC. |
| K983084 |
09/03/1998 |
QUANTA LITE RF IGA ELISA |
INOVA DIAGNOSTICS, INC. |
| K983083 |
09/03/1998 |
QUANTA LITE RF IGG ELISA |
INOVA DIAGNOSTICS, INC. |
| K072632 |
09/18/2007 |
QUANTA PLEX CELIAC IGG PROFILE |
INOVA DIAGNOSTICS, INC. |
| K954380 |
09/19/1995 |
QUANTA LITE SSDNA |
INOVA DIAGNOSTICS, INC. |
| K072967 |
10/22/2007 |
QUANTA LITE F-ACTIN IGA ELISA |
INOVA DIAGNOSTICS, INC. |
| K955021 |
11/02/1995 |
QUANTA LITE PR3 |
INOVA DIAGNOSTICS, INC. |
| K955022 |
11/02/1995 |
QUANTA LITE MPO |
INOVA DIAGNOSTICS, INC. |
| K984137 |
11/18/1998 |
QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA |
INOVA DIAGNOSTICS, INC. |
| K984234 |
11/25/1998 |
QUANTA LITE LYME IGM ELISA |
INOVA DIAGNOSTICS, INC. |
| K984222 |
11/25/1998 |
QUANTA LITE LYME IGG ELISA |
INOVA DIAGNOSTICS, INC. |
| K063565 |
11/28/2006 |
QUANTA LITE SS-A 52 ELISA |
INOVA DIAGNOSTICS, INC. |
| K984336 |
12/03/1998 |
QUANTA LITE GBM ELISA |
INOVA DIAGNOSTICS, INC. |
| K964986 |
12/13/1996 |
QUANTA LITE IGA GLIADIN ELISA |
INOVA DIAGNOSTICS, INC. |
| K964985 |
12/13/1996 |
QUANTA LITE IGG GLIADIN ELISA |
INOVA DIAGNOSTICS, INC. |
| K063818 |
12/22/2006 |
QUANTA PLEX CELIAC IGA PROFILE |
INOVA DIAGNOSTICS, INC. |
| K024334 |
12/26/2002 |
QUANTA LITE H.PYLORI IGA ELISA |
INOVA DIAGNOSTICS, INC. |
| K192916 |
10/15/2019 |
NOVA Lite DAPI dsDNA Crithidia luciliae Kit |
Inova Diagnostics, Inc. |
| K090755 |
03/20/2009 |
QUANTA LITE APS/PT IGG AND IGM ELISA |
INOVA DIAGNOSTICS, INC. |
| K062708 |
09/11/2006 |
QUANTA LITE CELIAC DGP SCREEN |
INOVA DIAGNOSTICS, INC. |
| K150155 |
01/23/2015 |
NOVA Lite DAPI ANA Kit |
INOVA DIAGNOSTICS, INC. |
| K161258 |
05/04/2016 |
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit |
INOVA DIAGNOSTICS, INC. |
| K141210 |
05/09/2014 |
QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS |
INOVA DIAGNOSTICS, INC. |
| K141328 |
05/21/2014 |
QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS |
INOVA DIAGNOSTICS, INC. |
| K151429 |
05/28/2015 |
QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols |
INOVA DIAGNOSTICS, INC. |
| K152013 |
07/21/2015 |
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls |
INOVA DIAGNOSTICS, INC. |
| K152635 |
09/15/2015 |
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls |
INOVA DIAGNOSTICS, INC. |
| K152875 |
09/30/2015 |
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls |
INOVA DIAGNOSTICS, INC. |
| K153150 |
11/02/2015 |
AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 |
Inova Diagnostics, Inc. |
| K123593 |
11/21/2012 |
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, |
INOVA DIAGNOSTICS, INC. |
| DEN140039 |
12/15/2014 |
NOVA View Automated Fluorescense Microscope |
INOVA DIAGNOSTICS, INC. |
| K113863 |
12/30/2011 |
QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS |
INOVA DIAGNOSTICS, INC. |
| K143754 |
12/31/2014 |
QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 |
INOVA DIAGNOSTICS, INC. |
| K000535 |
02/17/2000 |
QUANTA LITE LKM-1 ELISA |
INOVA DIAGNOSTICS, INC. |
| K050662 |
03/15/2005 |
QUANTA LITE SP100 ELISA |
INOVA DIAGNOSTICS, INC. |
| K040885 |
04/05/2004 |
QUANTA LITE GP210 ELISA |
INOVA DIAGNOSTICS, INC. |
| K061842 |
06/29/2006 |
QUANTA LITE PBC SCREEN IGG/IGA ELISA |
INOVA DIAGNOSTICS, INC. |
| K061841 |
06/29/2006 |
QUANTA LITE INTRINSIC FACTOR ELISA |
INOVA DIAGNOSTICS, INC. |
| K994004 |
11/24/1999 |
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT |
INOVA DIAGNOSTICS, INC. |
| K141655 |
06/20/2014 |
QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS |
INOVA DIAGNOSTICS, INC. |
| K073145 |
11/08/2007 |
QUANTA LITE H-TTG SCREEN |
INOVA DIAGNOSTICS, INC. |
| K112545 |
09/01/2011 |
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM |
INOVA DIAGNOSTICS, INC. |
| K122923 |
09/24/2012 |
QUANTA FLASH ENA7 |
INOVA DIAGNOSTICS, INC. |
| K163525 |
12/15/2016 |
QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls |
Inova Diagnostics, Inc. |
| K190088 |
01/17/2019 |
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents |
Inova Diagnostics, Inc. |
| K170993 |
04/03/2017 |
QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer |
Inova Diagnostics, Inc. |
| K180971 |
04/13/2018 |
QUANTA Flash Calprotectin and Fecal Extraction Device |
Inova Diagnostics, Inc. |
| K180975 |
04/13/2018 |
QUANTA Flash HMGCR Reagents |
Inova Diagnostics, Inc. |
| K141274 |
05/16/2014 |
QUANTA FLASH ┐2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-┐2GPI DOMAIN1; CONTROLS. |
INOVA DIAGNOSTICS, INC. |
| K163538 |
12/16/2016 |
QUANTA Flash« LKM-1 Reagents, QUANTA Flash« LKM-1 Calibrators, QUANTA Flash« LKM-1 Controls |
INOVA DIAGNOSTICS, INC. |
| K120817 |
03/19/2012 |
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA |
INOVA DIAGNOSTICS, INC. |
| K111414 |
05/20/2011 |
QUANTA FLASH (TM) DGP SCREEN |
INOVA DIAGNOSTICS, INC. |
| K101644 |
06/10/2010 |
QUANTA FLASH H-TTG IGG |
INOVA DIAGNOSTICS, INC. |
| K072944 |
10/17/2007 |
QUANTA LITE CCP3.1 IGG/IGA ELISA |
INOVA DIAGNOSTICS, INC. |
| K094060 |
12/31/2009 |
QUANTA FLASH H-TTG IGA |
INOVA DIAGNOSTICS, INC. |
| K081248 |
05/02/2008 |
QUANTA LITE OMP PLUS ELISA |
INOVA DIAGNOSTICS, INC. |
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