Inova Diagnostics, Inc.
FDA 510(k) medical device clearances.
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.