Inova Diagnostics, Inc.
Inova Diagnostics, Inc. holds FDA 510(k) medical device clearances, first cleared 1988, most recent 2026.
Top product codes for Inova Diagnostics, Inc.
Recent clearances by Inova Diagnostics, Inc.
1–100 of 138- K243979 — Aptiva APS IgA Reagent
- K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent
- K213403 — Aptiva CTD Essential Reagent
- K200230 — Aptiva Celiac Disease IgG Reagent
- K193604 — Aptiva Celiac Disease IgA Reagent
- K192916 — NOVA Lite DAPI dsDNA Crithidia luciliae Kit
- K190088 — QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
- K180971 — QUANTA Flash Calprotectin and Fecal Extraction Device
- K180975 — QUANTA Flash HMGCR Reagents
- K170993 — QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer
- K163538 — QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls
- K163525 — QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls
- K161258 — NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
- K152635 — QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls
- K152013 — QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls
- K151429 — QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols
- K152875 — QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
- K153150 — AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
- K143754 — QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3
- DEN140039 — NOVA View Automated Fluorescense Microscope
- K150155 — NOVA Lite DAPI ANA Kit
- K141655 — QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS
- K141274 — QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.
- K141328 — QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS
- K141210 — QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS
- K123880 — QUANTA FLASH CENTROMERE
- K122923 — QUANTA FLASH ENA7
- K123593 — QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,
- K120817 — QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
- K113863 — QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS
- K112545 — QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM
- K111414 — QUANTA FLASH (TM) DGP SCREEN
- K101644 — QUANTA FLASH H-TTG IGG
- K094060 — QUANTA FLASH H-TTG IGA
- K090755 — QUANTA LITE APS/PT IGG AND IGM ELISA
- K081248 — QUANTA LITE OMP PLUS ELISA
- K072944 — QUANTA LITE CCP3.1 IGG/IGA ELISA
- K073145 — QUANTA LITE H-TTG SCREEN
- K072632 — QUANTA PLEX CELIAC IGG PROFILE
- K072967 — QUANTA LITE F-ACTIN IGA ELISA
- K063818 — QUANTA PLEX CELIAC IGA PROFILE
- K070066 — QUANTA LITE RNA POL III ELISA
- K063565 — QUANTA LITE SS-A 52 ELISA
- K070083 — QUANTA LITE H-TTG/DGP SCREEN
- K061841 — QUANTA LITE INTRINSIC FACTOR ELISA
- K062708 — QUANTA LITE CELIAC DGP SCREEN
- K061842 — QUANTA LITE PBC SCREEN IGG/IGA ELISA
- K052264 — QUANTA LITE CCP3 IGG ELISA
- K052262 — QUANTA LITE M2 EP (MIT3) ELISA
- K052142 — QUANTA LITE GLIADIN IGG II
- K052143 — QUANTA LITE GLIADIN IGA II
- K050662 — QUANTA LITE SP100 ELISA
- K050715 — QUANTA PLEX ANCA PROFILE
- K040885 — QUANTA LITE GP210 ELISA
- K040160 — QUANTA PLEX SLE PROFILE 8
- K031450 — QUANTA PLEX ENA PROFILE 6
- K030681 — QUANTA PLEX ENA PROFILE 5
- K024334 — QUANTA LITE H.PYLORI IGA ELISA
- K021648 — QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA
- K021482 — QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA
- K020414 — QUANTA LITE CCP ELISA
- K011140 — QUANTA PLEX ENA PROFILE 4
- K011566 — QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
- K011570 — QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
- K000733 — QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA
- K010558 — QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA
- K003959 — QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA
- DEN000007 — QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
- K000535 — QUANTA LITE LKM-1 ELISA
- K994004 — QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT
- K991657 — QUANTA LITE ANA ELISA
- K984222 — QUANTA LITE LYME IGG ELISA
- K984234 — QUANTA LITE LYME IGM ELISA
- K984336 — QUANTA LITE GBM ELISA
- K984137 — QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA
- K982790 — QUANTA LITE H. PYLORI IGG ELISA
- K983083 — QUANTA LITE RF IGG ELISA
- K983084 — QUANTA LITE RF IGA ELISA
- K982603 — QUANTA LITE CHROMATIN ELISA
- K982023 — PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
- K982366 — QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA
- K981857 — QUANTA LITE TPO ELISA
- K981328 — QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT
- K981330 — QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT
- K981237 — QUANTA LITE RIBOSOME P ELISA
- K980312 — NOVA LITE ENDOMYSIAL
- K980230 — QUANTA LITE B2 GPI SCREEN
- K971304 — QUANTA LITE REBELLA IGG
- K971441 — QUANTA LITE TOXOPLASMA IGG
- K971335 — QUANTA LITE CMV IGG ELISA
- K973006 — QUANTA LITE B2 GPI IGA
- K973014 — QUANTA LITE B2GPI IGM
- K971620 — QUANTA LITE RUBEOLA (MEASLES) IGG
- K970551 — QUANTA LITE B2GPI IGG
- K971614 — QUANTA LITE RF IGM
- K964986 — QUANTA LITE IGA GLIADIN ELISA
- K964985 — QUANTA LITE IGG GLIADIN ELISA
- K961340 — NOVA LITE ANCA
- K961913 — QUANTA LITE ENA 6 ELISA
- K955021 — QUANTA LITE PR3
Data sourced from openFDA. This site is unofficial and independent of the FDA.