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Inova Diagnostics, Inc.

138 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Aptiva APS IgA Reagent (K243979)Inova Diagnostics, Inc.2026-02-06
Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (K223093)Inova Diagnostics, Inc.2024-12-17
Aptiva CTD Essential Reagent (K213403)Inova Diagnostics, Inc.2023-09-29
Aptiva Celiac Disease IgG Reagent (K200230)Inova Diagnostics, Inc.2021-08-26
Aptiva Celiac Disease IgA Reagent (K193604)Inova Diagnostics, Inc.2021-06-16
NOVA Lite DAPI dsDNA Crithidia luciliae Kit (K192916)Inova Diagnostics, Inc.2020-12-11
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents (K190088)Inova Diagnostics, Inc.2019-04-17
QUANTA Flash Calprotectin and Fecal Extraction Device (K180971)Inova Diagnostics, Inc.2018-10-16
QUANTA Flash HMGCR Reagents (K180975)Inova Diagnostics, Inc.2018-06-25
QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer (K170993)Inova Diagnostics, Inc.2017-12-22
QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls (K163538)Inova Diagnostics, Inc.2017-09-06
QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls (K163525)Inova Diagnostics, Inc.2017-09-05
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit (K161258)Inova Diagnostics, Inc.2017-02-03
QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls (K152635)Inova Diagnostics, Inc.2016-06-01
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls (K152013)Inova Diagnostics, Inc.2016-04-11
QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols (K151429)Inova Diagnostics, Inc.2016-02-12
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls (K152875)Inova Diagnostics, Inc.2015-12-21
AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 (K153150)Inova Diagnostics, Inc.2015-11-24
QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 (K143754)Inova Diagnostics, Inc.2015-09-21
NOVA View Automated Fluorescense Microscope (DEN140039)Inova Diagnostics, Inc.2015-04-09
NOVA Lite DAPI ANA Kit (K150155)Inova Diagnostics, Inc.2015-04-08
QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS (K141655)Inova Diagnostics, Inc.2015-03-05
QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS. (K141274)Inova Diagnostics, Inc.2015-02-13
QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS (K141328)Inova Diagnostics, Inc.2015-02-12
QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS (K141210)Inova Diagnostics, Inc.2015-01-29
QUANTA FLASH CENTROMERE (K123880)Inova Diagnostics, Inc.2014-02-07
QUANTA FLASH ENA7 (K122923)Inova Diagnostics, Inc.2013-05-07
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, (K123593)Inova Diagnostics, Inc.2013-04-17
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA (K120817)Inova Diagnostics, Inc.2013-02-26
QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS (K113863)Inova Diagnostics, Inc.2012-09-20
QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM (K112545)Inova Diagnostics, Inc.2012-07-31
QUANTA FLASH (TM) DGP SCREEN (K111414)Inova Diagnostics, Inc.2011-10-20
QUANTA FLASH H-TTG IGG (K101644)Inova Diagnostics, Inc.2011-03-23
QUANTA FLASH H-TTG IGA (K094060)Inova Diagnostics, Inc.2010-10-13
QUANTA LITE APS/PT IGG AND IGM ELISA (K090755)Inova Diagnostics, Inc.2010-02-01
QUANTA LITE OMP PLUS ELISA (K081248)Inova Diagnostics, Inc.2008-10-27
QUANTA LITE CCP3.1 IGG/IGA ELISA (K072944)Inova Diagnostics, Inc.2008-03-05
QUANTA LITE H-TTG SCREEN (K073145)Inova Diagnostics, Inc.2008-02-12
QUANTA PLEX CELIAC IGG PROFILE (K072632)Inova Diagnostics, Inc.2008-02-11
QUANTA LITE F-ACTIN IGA ELISA (K072967)Inova Diagnostics, Inc.2008-01-28
QUANTA PLEX CELIAC IGA PROFILE (K063818)Inova Diagnostics, Inc.2007-06-20
QUANTA LITE RNA POL III ELISA (K070066)Inova Diagnostics, Inc.2007-04-11
QUANTA LITE SS-A 52 ELISA (K063565)Inova Diagnostics, Inc.2007-04-04
QUANTA LITE H-TTG/DGP SCREEN (K070083)Inova Diagnostics, Inc.2007-03-12
QUANTA LITE INTRINSIC FACTOR ELISA (K061841)Inova Diagnostics, Inc.2006-12-22
QUANTA LITE CELIAC DGP SCREEN (K062708)Inova Diagnostics, Inc.2006-12-13
QUANTA LITE PBC SCREEN IGG/IGA ELISA (K061842)Inova Diagnostics, Inc.2006-10-18
QUANTA LITE CCP3 IGG ELISA (K052264)Inova Diagnostics, Inc.2005-11-23
QUANTA LITE M2 EP (MIT3) ELISA (K052262)Inova Diagnostics, Inc.2005-10-27
QUANTA LITE GLIADIN IGA II (K052143)Inova Diagnostics, Inc.2005-10-04
QUANTA LITE GLIADIN IGG II (K052142)Inova Diagnostics, Inc.2005-10-04
QUANTA LITE SP100 ELISA (K050662)Inova Diagnostics, Inc.2005-06-13
QUANTA PLEX ANCA PROFILE (K050715)Inova Diagnostics, Inc.2005-05-12
QUANTA LITE GP210 ELISA (K040885)Inova Diagnostics, Inc.2004-06-25
QUANTA PLEX SLE PROFILE 8 (K040160)Inova Diagnostics, Inc.2004-03-08
QUANTA PLEX ENA PROFILE 6 (K031450)Inova Diagnostics, Inc.2003-06-25
QUANTA PLEX ENA PROFILE 5 (K030681)Inova Diagnostics, Inc.2003-04-24
QUANTA LITE H.PYLORI IGA ELISA (K024334)Inova Diagnostics, Inc.2003-03-27
QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA (K021648)Inova Diagnostics, Inc.2002-09-20
QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA (K021482)Inova Diagnostics, Inc.2002-07-30
QUANTA LITE CCP ELISA (K020414)Inova Diagnostics, Inc.2002-04-29
QUANTA PLEX ENA PROFILE 4 (K011140)Inova Diagnostics, Inc.2001-07-27
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA (K011566)Inova Diagnostics, Inc.2001-07-09
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA (K011570)Inova Diagnostics, Inc.2001-07-09
QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA (K000733)Inova Diagnostics, Inc.2001-05-21
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA (K010558)Inova Diagnostics, Inc.2001-04-03
QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA (K003959)Inova Diagnostics, Inc.2001-01-22
QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA (DEN000007)Inova Diagnostics, Inc.2000-08-16
QUANTA LITE LKM-1 ELISA (K000535)Inova Diagnostics, Inc.2000-06-07
QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT (K994004)Inova Diagnostics, Inc.2000-01-27
QUANTA LITE ANA ELISA (K991657)Inova Diagnostics, Inc.1999-06-17
QUANTA LITE LYME IGG ELISA (K984222)Inova Diagnostics, Inc.1999-04-15
QUANTA LITE LYME IGM ELISA (K984234)Inova Diagnostics, Inc.1999-04-15
QUANTA LITE GBM ELISA (K984336)Inova Diagnostics, Inc.1999-02-08
QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA (K984137)Inova Diagnostics, Inc.1999-01-28
QUANTA LITE H. PYLORI IGG ELISA (K982790)Inova Diagnostics, Inc.1998-11-04
QUANTA LITE RF IGA ELISA (K983084)Inova Diagnostics, Inc.1998-11-04
QUANTA LITE RF IGG ELISA (K983083)Inova Diagnostics, Inc.1998-11-04
QUANTA LITE CHROMATIN ELISA (K982603)Inova Diagnostics, Inc.1998-10-07
PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT (K982023)Inova Diagnostics, Inc.1998-09-04
QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA (K982366)Inova Diagnostics, Inc.1998-08-27
QUANTA LITE TPO ELISA (K981857)Inova Diagnostics, Inc.1998-07-29
QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT (K981330)Inova Diagnostics, Inc.1998-06-19
QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT (K981328)Inova Diagnostics, Inc.1998-06-19
QUANTA LITE RIBOSOME P ELISA (K981237)Inova Diagnostics, Inc.1998-06-05
NOVA LITE ENDOMYSIAL (K980312)Inova Diagnostics, Inc.1998-04-02
QUANTA LITE B2 GPI SCREEN (K980230)Inova Diagnostics, Inc.1998-03-24
QUANTA LITE REBELLA IGG (K971304)Inova Diagnostics, Inc.1998-01-02
QUANTA LITE TOXOPLASMA IGG (K971441)Inova Diagnostics, Inc.1997-12-02
QUANTA LITE CMV IGG ELISA (K971335)Inova Diagnostics, Inc.1997-12-01
QUANTA LITE B2GPI IGM (K973014)Inova Diagnostics, Inc.1997-10-20
QUANTA LITE B2 GPI IGA (K973006)Inova Diagnostics, Inc.1997-10-20
QUANTA LITE RUBEOLA (MEASLES) IGG (K971620)Inova Diagnostics, Inc.1997-07-22
QUANTA LITE B2GPI IGG (K970551)Inova Diagnostics, Inc.1997-06-24
QUANTA LITE RF IGM (K971614)Inova Diagnostics, Inc.1997-06-20
QUANTA LITE IGA GLIADIN ELISA (K964986)Inova Diagnostics, Inc.1997-06-02
QUANTA LITE IGG GLIADIN ELISA (K964985)Inova Diagnostics, Inc.1997-05-30
NOVA LITE ANCA (K961340)Inova Diagnostics, Inc.1996-07-10
QUANTA LITE ENA 6 ELISA (K961913)Inova Diagnostics, Inc.1996-07-10
QUANTA LITE PR3 (K955021)Inova Diagnostics, Inc.1996-03-19
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