FDA.reportPublic FDA data

INOVA DIAGNOSTICS, INC.

Matched from indexed company URL: Inova Diagnostics, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20269942026994INOVA DIAGNOSTICS, INC.1Y2026-01-019900 Old Grove Rd SAN DIEGO CA US 92131

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00195126001021NOVA Lite® IFA Hu (ANNA-1) Positive Control - 1 x 0.5 Hu (ANNA-1) Positive Control1-800-545-9495TechSupport.na@werfen.com
00195126001038NOVA Lite® IFA Pancreatic Islet Cell Positive Control - 1 x 0.5mL Pancreatic Islet Cell Pos. Ctl.1-800-545-9495TechSupport.na@werfen.com
00195126001045NOVA Lite® IFA Yo (PCA-1) Positive Control - 1 x 0.5mL Yo (PCA-1) Positive Control1-800-545-9495TechSupport.na@werfen.com
08426950454373QUANTA Lite® ANA ELISA - 1. 1x ANA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ANA ELISA Low Positive4. 1x 1.2mL prediluted ANA ELISA High Positive5. 1x 50mL ANA Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HS HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid1-800-545-9495support@inovadx.com
08426950456193NOVA Lite® HEp-2 ANA Kit - 1. 20x Hep- 2 ANA Slide (12 well)2. 1x 0.5mL IFA System Negative Control3. 1x 15mL FITC IgG Conjugate 4. 1x 7mL Mounting Medium5. 2x 25mL PBS II Concentrate (40x)6 .1x Coverlips, 20 each7. 1x 0.5mL ANA Titratable Pattern1-800-545-9495support@inovadx.com
08430793040761Aptiva® APS IgG Calibrators - 1.Aptiva APS IgG Calibrator 1 (2x0.3mL) 2. Aptiva APS IgG Calibrator 2 (2x0.3mL) 3. Aptiva APS IgG Calibrator 3 (2x0.3mL)1-800-678-0710TechSupport.na@werfen.com
08430793041140Aptiva® Optical Cleaning Solution - The Aptiva Optical Cleaning Solution is for use on the Inova Diagnostics Aptiva Digital Multi-Analyte System to clean the instrument Optical Module (OM)1-800-678-0710TechSupport.na@werfen.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
347201734035087K993727BINDAZYME ANTI-DSDNA EIA KITLRM1999-12-21
347201048614727K991657QUANTA LITE ANA ELISALLL1999-06-17
347201670348512K984336QUANTA LITE GBM ELISAMVJ1999-02-08
347201550050415K983084QUANTA LITE RF IGA ELISADHR1998-11-04
347201608502001K983083QUANTA LITE RF IGG ELISADHR1998-11-04
347201545027722K982790QUANTA LITE H. PYLORI IGG ELISALYR1998-11-04
347201345899573K982603QUANTA LITE CHROMATIN ELISALLL1998-10-07
347201537610714K982366QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISAMVM1998-08-27
347201451919244K981857QUANTA LITE TPO ELISALLL1998-07-29
347201882142720K981330QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KITMOB1998-06-19
347202042229501K981328QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KITMOB1998-06-19
347201876162747K981237QUANTA LITE RIBOSOME P ELISAMQA1998-06-05
347201055586509K981209MONKEY OESOPHAGUS IFA DIAGNOSTIC TEST KITSMVM1998-10-22
347201837558811K981030BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KITMOB1998-07-20
347201254630630K981029BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KITMOB1998-07-20
347201920817720K980230QUANTA LITE B2 GPI SCREENMSV1998-03-24
347201262812880K973014QUANTA LITE B2GPI IGMMSV1997-10-20
347201678907943K973006QUANTA LITE B2 GPI IGAMSV1997-10-20
347201763409652K971614QUANTA LITE RF IGMDHR1997-06-20
347201390004229K970551QUANTA LITE B2GPI IGGMSV1997-06-24
347201770488290K965133ANCA COMBI DIAGNOSTIC TEST KITMOB1997-05-21
347201199006594K964986QUANTA LITE IGA GLIADIN ELISAMST1997-06-02
347201580257627K964985QUANTA LITE IGG GLIADIN ELISAMST1997-05-30
347201173689499K961913QUANTA LITE ENA 6 ELISALLL1996-07-10
347201283713761K961340NOVA LITE ANCAMOB1996-07-10
347201160813636K955431RIT LIVER, KIDNEY, STOMACH IFA KITDBL1996-04-23
347201349055463K954380QUANTA LITE SSDNALJM1996-02-29
347201269875255K953366QUANTA LITE IGA ACA (HRP)MID1995-09-01
347201761240518K953291QUANTA LITE ACA SCREEN (HRP)MID1995-08-29
347201305823427K946385QUANTA LITE ACA IGM (HRP)MID1995-07-18
347201833022351K946034QUANTA LITE(TM) IGG (HRP)MID1995-07-18
347201950911624K943076QUANTA LITE ENA 5 ELISA KITLLL1994-10-25
347201611367989K934053QUANTA LITE(TM) HISTONE ELISALLL1993-12-21
347201581414188K930486QUANTA LITE(TM) THYROID T ELISADDC1993-03-15
347201206874616K926562QUANTA LITE(TM) JO-1 ELISA KITLLL1993-03-04
347201692378276K924898QUANTA LITE(TM) SCL-70 ELISALLL1992-12-15
347201601566457K922833QUANTA LITE RNP ELISALLL1992-09-18
347201500270281K922832QUANTA LITE SS-B ELISALLL1992-09-18
347201344353349K922831QUANTA LITE SM ELISALLL1992-09-18
347201252205292K922830QUANTA LITE SS-A ELISALLL1992-09-18
347201109815954K922829QUANTA LITE ENA ELISALLL1992-09-18
347201180357190K904224NOVA LITE TM THYROIDJZO1990-10-15
347201224991177K903898QUANTA LITE TM DSDNALLL1990-09-05
347201806476943K901596NOVA LITE(TM) ANA KSLDHN1990-05-02
347201540927946K881340NOVA LITE(TM) AUTOANTIBODY CONTROLSLLL1988-06-08
347201583377553K881339NOVA LITE(TM) ANA PLUSLLL1988-04-21
347201888851944K880742NOVA LITE(TM) DSDNADHN1988-03-25
347201735564790K880736NOVA LITE(TM) ANALLL1988-03-25
347201506068232K243979Aptiva APS IgA ReagentMSV2026-02-06
347201572064932K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentMID2024-12-17
347201523618676K213403Aptiva CTD Essential ReagentLLL2023-09-29
347201802154783K200230Aptiva Celiac Disease IgG ReagentMVM2021-08-26
347201832219793K193604Aptiva Celiac Disease IgA ReagentMVM2021-06-16
347201888713813K192916NOVA Lite DAPI dsDNA Crithidia luciliae KitKTL2020-12-11
347201438539730K191592CalprestNG, EasyCalNXO2019-07-10
347201399243879K190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsDHR2019-04-17
347201821315703K180975QUANTA Flash HMGCR ReagentsLLL2018-06-25
347201799548336K180971QUANTA Flash Calprotectin and Fecal Extraction DeviceNXO2018-10-16
347201627701102K170993QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction BufferNXO2017-12-22
347201555476912K163538QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 ControlsNBS2017-09-06
347201945069750K163525QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) ControlsDBM2017-09-05
347201040191880K161258NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitMOB2017-02-03
347201865362297K160447Calprest NGNXO2016-11-10
347201960751830K153150AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000PIV2015-11-24
347201007284345K152875QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 ControlsMSV2015-12-21
347201863685900K152635QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 ControlsLLL2016-06-01
347202069976469K152013QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA ControlsLSW2016-04-11
347201277430781K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsLLL2016-02-12
347201938840725K150155NOVA Lite DAPI ANA KitDHN2015-04-08
347201901952665K143754QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3NHX2015-09-21
347201676592829K141655QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLSOBE2015-03-05
347202065479762K141328QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLSLLL2015-02-12
347201931703442K141210QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLSLLL2015-01-29
347201315677513K130945CALPRESTNXO2014-01-16
347201639586014K123880QUANTA FLASH CENTROMERELJM2014-02-07
347201788924583K123593QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,LKP2013-04-17
347201304930104K122923QUANTA FLASH ENA7LLL2013-05-07
347201230275062K120817QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGAMID2013-02-26
347201981195162K113863QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORSMST2012-09-20
347201322530214K112545QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBMMOB2012-07-31
347201286369195K111414QUANTA FLASH (TM) DGP SCREENMST2011-10-20
347201529569518K101644QUANTA FLASH H-TTG IGGMVM2011-03-23
347201007771339K094060QUANTA FLASH H-TTG IGAMVM2010-10-13
347201065424695K092181HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLSMID2010-03-11
347201050333535K091556HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLSMSV2010-05-21
347201427979194K090755QUANTA LITE APS/PT IGG AND IGM ELISAOPN2010-02-01
347201692565740K081248QUANTA LITE OMP PLUS ELISAOKM2008-10-27
347201329177378K073145QUANTA LITE H-TTG SCREENMVM2008-02-12
347201153548732K072967QUANTA LITE F-ACTIN IGA ELISAMVM2008-01-28
347201617764541K072944QUANTA LITE CCP3.1 IGG/IGA ELISANHX2008-03-05
347201333071313K070083QUANTA LITE H-TTG/DGP SCREENMST2007-03-12
347201748463866K070066QUANTA LITE RNA POL III ELISANYO2007-04-11
347201617562598K063565QUANTA LITE SS-A 52 ELISAOBE2007-04-04
347201586607396K062708QUANTA LITE CELIAC DGP SCREENMST2006-12-13
347201925476624K062183FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KITLRM2006-11-21
347201168173624K061842QUANTA LITE PBC SCREEN IGG/IGA ELISANRI2006-10-18
347201301759776K061841QUANTA LITE INTRINSIC FACTOR ELISALIG2006-12-22
347201836672412K052264QUANTA LITE CCP3 IGG ELISANHX2005-11-23
347201292730001K052262QUANTA LITE M2 EP (MIT3) ELISADBM2005-10-27
347201280041280K052143QUANTA LITE GLIADIN IGA IIMST2005-10-04
347201939225283K052142QUANTA LITE GLIADIN IGG IIMST2005-10-04
347201946394871K050662QUANTA LITE SP100 ELISANUM2005-06-13
347201728527116K040885QUANTA LITE GP210 ELISANRI2004-06-25
347201875479606K040466BINDAZYME HUMAN ANTI TISSUE TRANSGLUTAMINASE IGA AND IGG EIA DIAGNOSTIC TEST KITSMVM2004-07-16
347201907881586K032240BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KITMID2003-09-29
347201245624373K031563BINDAZYME CLQ CIC EIA KITDAK2003-09-10
347201735260499K024334QUANTA LITE H.PYLORI IGA ELISALYR2003-03-27
347201785077827K021648QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISANJF2002-09-20
347201954600929K021482QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISANIY2002-07-30
347201962780660K011570QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISAMVM2001-07-09
347201982509282K011566QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISAMVM2001-07-09
347201226865973K010558QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISAMLE2001-04-03
347201502863433K003959QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISALJM2001-01-22
347201264384754K000733QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISANBT2001-05-21
347201051291847K000535QUANTA LITE LKM-1 ELISANBS2000-06-07
347201468368408DEN140039NOVA View Automated Fluorescense MicroscopePIV2015-04-09
347201349281767DEN000007QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISANBT2000-08-16
347201100963200
347201162103156
347201264971786

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLL242023-09-29
MVM112021-08-26
MID82024-12-17
MOB82017-02-03
MST82012-09-20
MSV72026-02-06
NXO52019-07-10
DHR42019-04-17
NHX32015-09-21
DHN32015-04-08
LJM32014-02-07
NBS22017-09-06
DBM22017-09-05
PIV22015-11-24
OBE22015-03-05
LRM22006-11-21
NRI22006-10-18
LYR22003-03-27
NBT22001-05-21
KTL12020-12-11
LSW12016-04-11
LKP12013-04-17
OPN12010-02-01
OKM12008-10-27
NYO12007-04-11
LIG12006-12-22
NUM12005-06-13
DAK12003-09-10
NJF12002-09-20
NIY12002-07-30
MLE12001-04-03
MVJ11999-02-08
MQA11998-06-05
DBL11996-04-23
DDC11993-03-15
JZO11990-10-15

PMN#

133 records. Showing 1-40. Next

GUDID#

QUANTA Lite® C1q CIC ELISA - 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. C1q CIC ELISA Plate: 12 breakapart 8 well strips coated with human C1q. Each plate is packaged in a re-sealable foil bag containing two desiccant pouch. 4.ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use5.C1q CIC Calibrator A- E: 5 bottles, each containing 1.2mL of diluted aggregated human IgG, with the following concentrations of immune complex: 100, 33.3, 11.1, 3.7, 1.23 microgram Eq/mL. Ready to use.6. C1q CIC Positive Control: 1 bottle containing 1.2mL of diluted aggregated human IgG. The expected value is given on the QC certificate. Ready to use.7. Type III Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored yellow, ready to use.8.HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.9. HRP C1q CIC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use.10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use.11. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use.

INOVA DIAGNOSTICS, INC.

2026-04-20

Aptiva® CTD Essential Calibrators - 1. Aptiva CTD Essential Calibrator 1 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL)2. Aptiva CTD Essential Calibrator 2 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL)3. Aptiva CTD Essential Calibrator 3 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL)4. Aptiva CTD Essential Calibrator 4 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL)5. Aptiva CTD Essential Calibrator 5 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL)6. Aptiva CTD Essential Calibrator 6 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.3mL)

INOVA DIAGNOSTICS, INC.

2023-12-14

Aptiva® CTD Essential Controls - 1. Aptiva CTD Essential Control 1 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.5mL)2. Aptiva CTD Essential Control 2 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.5mL)3. Aptiva CTD Essential Control 3 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.5mL)4. Aptiva CTD Essential Control 4 - Bovine derived serum, methylisothiazolone and bromonitrodioxane and ANA Positive Serum (2 x 0.5mL)

INOVA DIAGNOSTICS, INC.

2023-12-14

NOVA Lite®Rat Liver , Kidney, Stomach Kit - 1. 10 x Rat liver, kidney, stomach slide (5-well)2. 1 x 1mL ANA Homogeneous Pattern (prediluted)3. 1 x 1mL IFA System Negative Control (prediluted)4. 1 x 1mL Mitochondrial (AMA) Pattern (prediluted) 5. 1 x 1mL Smooth Muscle (ASMA) Pattern (prediluted) 6. 1 x 7mL FITC IgG (H&L) Conjugate 7. 1 x 3mL 1% Evans Blue Counterstain8. 2 x 25mL PBS II Buffer (x40 conc)9. 1 x 3mL Mounting Medium10. 20 x Blotters11. 10 x Coverslips 12. 1 x instruction leaflet

INOVA DIAGNOSTICS, INC.

2016-08-31

NOVA Lite®Rat Liver , Kidney, Stomach Kit - 1. 25 x Rat liver, kidney, stomach slide (10-well)2. 1 x 1mL ANA Homogeneous Pattern (prediluted)3. 1 x 1mL IFA System Negative Control (prediluted)4. 1 x 1mL Mitochondrial (AMA) Pattern (prediluted) 5. 1 x 1mL Smooth Muscle (ASMA) Pattern (prediluted) 6. 1 x 15mL FITC IgG (H&L) Conjugate7. 1 x 3mL 1% Evans Blue Counterstain8. 2 x 25 PBS II Buffer (x40 conc)9. 1 x 10mL Mounting Medium10. 50 x Blotters11. 25 x Coverslips 12. 1 x instruction leaflet

INOVA DIAGNOSTICS, INC.

2016-08-31

Aptiva® Instrument System Cuvettes - The Instrument System Cuvettes are intended for use on the Inova Diagnostics Aptiva® Multi-Analyte Instrument. Instrument System Cuvettes are for single use as a reaction or dilution container in the Aptiva Multi-Analyte Instrument. Instrument System Cuvettes are required to ensure the functionality and performance of the Aptiva Multi-Analyte Instrument. Use of alternate cuvettes can negatively impact Aptiva Multi-Analyte Instrument results.

INOVA DIAGNOSTICS, INC.

2024-03-11

QUANTA-Lyser ® 3000 ELISA/IFA+ Incubator - QUANTA-Lyser instruments are fully automated benchtop processors for use in conjunction with certain reagents to measure a variety of analytes. QUANTA-Lyser is intended to automate slide and reagent barcode reading, sample dilution and distribution, reagent pipetting and dispensing, slide and plate washing, dispensing slide mounting medium in preparation for microscope analysis and photometric measurement of microwell plates.

INOVA DIAGNOSTICS, INC.

2024-03-11

200 records. Showing 1-40. Next