{
  "companyId": "60211",
  "slug": "inova-diagnostics-incorporated-60211",
  "name": "Inova Diagnostics Incorporated",
  "clearances": {
    "total": 136,
    "last12Months": 1,
    "first": "1988-03-25",
    "latest": "2026-02-06"
  },
  "medianReviewDays": 93,
  "productCodeCount": 41,
  "recalls": {
    "total": 4,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-1221-2018",
        "productCode": "JJE",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2018-01-26",
        "reason": "The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument."
      },
      {
        "resNumber": "Z-1222-2018",
        "productCode": "JJE",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2018-01-26",
        "reason": "The device power supply was not manufactured according to specification which can result in the loss of the protective grounding of the instrument."
      },
      {
        "resNumber": "Z-0280-2012",
        "productCode": "DHN",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2011-09-26",
        "reason": "The NOVA Lite ANA KSL kit label has the wrong fill volume for the IFA System Negative Control (P/N 508186) with 1mL.  The component in the kit is correctly labeled and filled with the 0.5mL fill volume."
      },
      {
        "resNumber": "Z-1942-2010",
        "productCode": "DAK",
        "status": "Terminated",
        "recallClass": null,
        "initiated": "2009-10-28",
        "reason": "The recall was initiated after the binding site notified Inova Diagnostics, inc. that the affected Bindazyme Human C1q binding Circulating Immune Complex EIA Kits may contain an ELISA plate labeled as \"tissue Transglutaminase Coated Wells\" instead of \"C1q Coated Wells\"."
      }
    ]
  },
  "registration": {
    "sites": 1,
    "countries": [
      "US"
    ]
  },
  "productCodes": [
    {
      "code": "LLL",
      "deviceName": "Extractable Antinuclear Antibody, Antigen And Control",
      "clearances": 37,
      "latest": "2023-09-29",
      "medianReviewDays": 71
    },
    {
      "code": "MVM",
      "deviceName": "Autoantibodies, Endomysial(Tissue Transglutaminase)",
      "clearances": 12,
      "latest": "2021-08-26",
      "medianReviewDays": 98
    },
    {
      "code": "MID",
      "deviceName": "System, Test, Anticardiolipin Immunological",
      "clearances": 9,
      "latest": "2024-12-17",
      "medianReviewDays": 218
    },
    {
      "code": "MOB",
      "deviceName": "Test System, Antineutrophil Cytoplasmic Antibodies (Anca)",
      "clearances": 8,
      "latest": "2017-02-03",
      "medianReviewDays": 107
    },
    {
      "code": "MST",
      "deviceName": "Antibodies, Gliadin",
      "clearances": 8,
      "latest": "2012-09-20",
      "medianReviewDays": 93
    },
    {
      "code": "MSV",
      "deviceName": "System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)",
      "clearances": 7,
      "latest": "2026-02-06",
      "medianReviewDays": 82
    },
    {
      "code": "DHN",
      "deviceName": "Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control",
      "clearances": 4,
      "latest": "2015-04-08",
      "medianReviewDays": 27
    },
    {
      "code": "DHR",
      "deviceName": "System, Test, Rheumatoid Factor",
      "clearances": 4,
      "latest": "2019-04-17",
      "medianReviewDays": 62
    },
    {
      "code": "NHX",
      "deviceName": "Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)",
      "clearances": 4,
      "latest": "2015-09-21",
      "medianReviewDays": 96
    },
    {
      "code": "LJM",
      "deviceName": "Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls",
      "clearances": 3,
      "latest": "2014-02-07",
      "medianReviewDays": 163
    },
    {
      "code": "LSR",
      "deviceName": "Reagent, Borrelia Serological Reagent",
      "clearances": 3,
      "latest": "2000-01-27",
      "medianReviewDays": 141
    },
    {
      "code": "DBM",
      "deviceName": "Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control",
      "clearances": 2,
      "latest": "2017-09-05",
      "medianReviewDays": 69
    },
    {
      "code": "JZO",
      "deviceName": "System, Test, Thyroid Autoantibody",
      "clearances": 2,
      "latest": "1993-03-16",
      "medianReviewDays": 32
    },
    {
      "code": "LYR",
      "deviceName": "Helicobacter Pylori",
      "clearances": 2,
      "latest": "2003-03-27",
      "medianReviewDays": 86
    },
    {
      "code": "NBS",
      "deviceName": "Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)",
      "clearances": 2,
      "latest": "2017-09-06",
      "medianReviewDays": 111
    },
    {
      "code": "NRI",
      "deviceName": "Autoantibodies, Nuclear Pore Glycoprotein Gp210",
      "clearances": 2,
      "latest": "2006-10-18",
      "medianReviewDays": 81
    },
    {
      "code": "NXO",
      "deviceName": "Calprotectin, Fecal",
      "clearances": 2,
      "latest": "2018-10-16",
      "medianReviewDays": 186
    },
    {
      "code": "OBE",
      "deviceName": "Anti-Ss-A 52 Autoantibodies",
      "clearances": 2,
      "latest": "2015-03-05",
      "medianReviewDays": 127
    },
    {
      "code": "DAS",
      "deviceName": "Igg (Fc Fragment Specific), Antigen, Antiserum, Control",
      "clearances": 1,
      "latest": "1998-09-04",
      "medianReviewDays": 87
    },
    {
      "code": "DBL",
      "deviceName": "Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control",
      "clearances": 1,
      "latest": "1998-04-02",
      "medianReviewDays": 65
    },
    {
      "code": "DDC",
      "deviceName": "Thyroglobulin, Antigen, Antiserum, Control",
      "clearances": 1,
      "latest": "1993-03-15",
      "medianReviewDays": 45
    },
    {
      "code": "DGC",
      "deviceName": "Ige, Antigen, Antiserum, Control",
      "clearances": 1,
      "latest": "1993-08-05",
      "medianReviewDays": 36
    },
    {
      "code": "KTL",
      "deviceName": "Anti-Dna Indirect Immunofluorescent Solid Phase",
      "clearances": 1,
      "latest": "2020-12-11",
      "medianReviewDays": 423
    },
    {
      "code": "LFX",
      "deviceName": "Enzyme Linked Immunoabsorbent Assay, Rubella",
      "clearances": 1,
      "latest": "1998-01-02",
      "medianReviewDays": 269
    },
    {
      "code": "LFZ",
      "deviceName": "Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus",
      "clearances": 1,
      "latest": "1997-12-01",
      "medianReviewDays": 235
    }
  ],
  "productCodesShown": 25,
  "productCodesTotal": "41",
  "recentClearances": [
    {
      "kNumber": "K243979",
      "deviceName": "Aptiva APS IgA Reagent",
      "productCode": "MSV",
      "decisionDate": "2026-02-06",
      "reviewDays": 410
    },
    {
      "kNumber": "K223093",
      "deviceName": "Aptiva APS IgG Reagent; Aptiva APS IgM Reagent",
      "productCode": "MID",
      "decisionDate": "2024-12-17",
      "reviewDays": 809
    },
    {
      "kNumber": "K213403",
      "deviceName": "Aptiva CTD Essential Reagent",
      "productCode": "LLL",
      "decisionDate": "2023-09-29",
      "reviewDays": 711
    },
    {
      "kNumber": "K200230",
      "deviceName": "Aptiva Celiac Disease IgG Reagent",
      "productCode": "MVM",
      "decisionDate": "2021-08-26",
      "reviewDays": 574
    },
    {
      "kNumber": "K193604",
      "deviceName": "Aptiva Celiac Disease IgA Reagent",
      "productCode": "MVM",
      "decisionDate": "2021-06-16",
      "reviewDays": 541
    },
    {
      "kNumber": "K192916",
      "deviceName": "NOVA Lite DAPI dsDNA Crithidia luciliae Kit",
      "productCode": "KTL",
      "decisionDate": "2020-12-11",
      "reviewDays": 423
    },
    {
      "kNumber": "K190088",
      "deviceName": "QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents",
      "productCode": "DHR",
      "decisionDate": "2019-04-17",
      "reviewDays": 90
    },
    {
      "kNumber": "K180971",
      "deviceName": "QUANTA Flash Calprotectin and Fecal Extraction Device",
      "productCode": "NXO",
      "decisionDate": "2018-10-16",
      "reviewDays": 186
    },
    {
      "kNumber": "K180975",
      "deviceName": "QUANTA Flash HMGCR Reagents",
      "productCode": "LLL",
      "decisionDate": "2018-06-25",
      "reviewDays": 73
    },
    {
      "kNumber": "K170993",
      "deviceName": "QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer",
      "productCode": "NXO",
      "decisionDate": "2017-12-22",
      "reviewDays": 263
    }
  ],
  "nameVariants": {
    "total": "4",
    "shown": [
      {
        "name": "INOVA DIAGNOSTICS, INC.",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "Inova Diagnostics Incorporated",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Inova Diagnostics Incorporated",
        "dataset": "device/recall",
        "method": "normalised"
      },
      {
        "name": "Inova Diagnostics, Inc.",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Inova%20Diagnostics%20Incorporated%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Inova%20Diagnostics%20Incorporated%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10
    }
  ],
  "retrievedAt": "2026-08-11T14:48:53.035Z"
}