{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 8
    }
  },
  "results": [
    {
      "proprietary_name": [
        "VENTANA MTAP (SP530) Rabbit Monoclonal Antibody",
        "Special Stains Nuclear Fast Red CS",
        "Special Stains Eosin CS",
        "VENTANA CD15 (MMA.P8) Mouse Monoclonal Antibody",
        "anti-p40 (BC28) Mouse Monoclonal Primary Antibody",
        "CONFIRM anti-Melanosome (HMB45) Mouse Monoclonal Primary Antibody",
        "VENTANA anti-p63 (4A4) Mouse Monoclonal Primary Antibody",
        "CONFIRM anti-CD45, LCA (RP2/18) Primary Antibody",
        "anti-Cytokeratin 5/6 (D5/16B4) Mouse Monoclonal Primary Antibody",
        "CONFIRM anti-S100 (4C4.9) Primary Antibody",
        "CONFIRM anti-Vimentin (V9) Primary Antibody",
        "VENTANA TFF3 (7F1.21) Mouse Monoclonal Primary Antibody",
        "CONFIRM Anti-CD34 (QBEnd/10) Mouse Monoclonal Primary Antibody",
        "ultraView Universal DAB Detection Kit",
        "FITC Anti-IgA Primary Antibody",
        "CONFIRM anti-CD56 (123C3) Mouse Monoclonal Primary Antibody",
        "Anti-Cytokeratin (CAM 5.2) Mouse Monoclonal Primary Antibody",
        "CONFIRM anti-MART-1/melan A (A103) Mouse Monoclonal Primary Antibody",
        "CONFIRM anti-HER-2/neu (4B5) Primary Antibody",
        "CONFIRM anti-S100 (Polyclonal) Primary Antibody",
        "CONFIRM anti-CD3 (2GV6) Rabbit Monoclonal Primary Antibody",
        "CONFIRM anti-Prostate Specific Antigen (PSA) Rabbit Polyclonal Antibody",
        "VENTANA PD-L1 SP263",
        "CONFIRM anti-CD30 (Ber-H2) Primary Antibody",
        "VENTANA PD-L1 (SP263) Assay (export)",
        "Negative Control (Monoclonal)",
        "Anti-Chromogranin A (LK2H10) Primary Antibody",
        "VENTANA anti-Cyclin D1 (SP4-R) Rabbit Monoclonal Primary Antibody",
        "ultraView Universal Alkaline Phosphatase Red Detection Kit",
        "FITC Anti-C3 Primary Antibody",
        "CONFIRM anti-Epidermal Growth Factor Receptor (3C6) Primary Antibody",
        "anti-EGFR E746-A750 del (SP111) Rabbit Monoclonal Primary Antibody",
        "VENTANA Basal Cell Cocktail (34bE12+p63)",
        "CONFIRM anti-CD4 (SP35) Rabbit Monoclonal Primary Antibody",
        "CONFIRM anti-CD20 (L26) Primary Antibody",
        "CONFIRM anti-Lambda Rabbit Polyclonal Primary Antibody",
        "FITC Anti-IgM Primary Antibody",
        "VENTANA PTEN (SP218) Rabbit Monoclonal Primary Antibody",
        "anti-ERG (EPR3864) Rabbit Monoclonal Primary Antibody",
        "VENTANA iView DAB Universal Kit (export)",
        "Amplification Kit",
        "Anti-Pan Keratin (AE1/AE3/PCK26) Primary Antibody",
        "VENTANA anti-E-Cadherin (36) Mouse Monoclonal Primary Antibo",
        "CONFIRM anti-MITF (C5/D5) Mouse Monoclonal Primary Antibody",
        "anti-c-MYC (Y69) Rabbit Monoclonal Primary Antibody",
        "CONFIRM anti-Cytokeratin 7 (SP52) Rabbit Monoclonal Primary Antibody",
        "Melanoma Triple Cocktail (HMB45+A103+T311) Primary Antibody",
        "iVIEW DAB Detection Kit",
        "Anti-CD43 (L60) Mouse Monoclonal Primary Antibody",
        "Anti-p504s (SP116) Rabbit Monoclonal Primary Antibody",
        "anti-CEA (TF 3H8-1) Primary Antibody",
        "CONFIRM anti-Synaptophysin (SP11) Rabbit Monoclonal Primary Antibody",
        "anti-bcl-2 (SP66) Rabbit Monoclonal Primary Antibody",
        "anti-MUC1 (H23) Mouse Monoclonal Primary Antibody",
        "FITC Anti-Kappa Primary Antibody",
        "CONFIRM anti-Vimentin (Vim 3B4) Primary Antibody",
        "CONFIRM anti-Total c-MET (SP44) Rabbit Monoclonal Primary Antibody",
        "Anti-Thyroid Transcription Factor-1 (SP141) Rabbit Monoclonal Primary Antibody",
        "CONFIRM anti-Kappa Rabbit Polyclonal Primary Antibody",
        "CONFIRM anti-Ki-67 (30-9) Rabbit Monoclonal Primary Antibody",
        "FITC Anti-Albumin Primary Antibody",
        "OptiView Amplification Kit",
        "CONFIRM anti-CD23 (SP23) Rabbit Monoclonal Primary Antibody",
        "VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal (export)",
        "Bluing Reagent",
        "Endogenous Biotin Blocking Kit",
        "VENTANA anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody",
        "CONFIRM anti-p53 (DO7) Primary Antibody",
        "anti-Cytokeratin 17 (SP95) Rabbit Monoclonal Primary Antibody",
        "CONFIRM anti-CD15 (MMA) Mouse Monoclonal Primary Antibody",
        "CONFIRM anti-bcl-2 (124) Mouse Monoclonal Primary Antibody",
        "CONFIRM anti-EMA (E29) Mouse Monoclonal Primary Antibody",
        "CONFIRM anti-CD5 (SP19) Rabbit Monoclonal Primary Antibody",
        "CONFIRM Negative Control Rabbit Ig",
        "FITC Anti-IgG Primary Antibody",
        "CONFIRM anti-Cytokeratin 20 (SP33) Rabbit Monoclonal Primary Antibody",
        "anti-Epithelial Related Antigen (MOC-31) Mouse Monoclonal Primary Antibody",
        "CONFIRM anti-Tyrosinase (T311) Mouse Monoclonal Primary Antibody",
        "CONFIRM anti-EGFR (5B7) Rabbit Monoclonal Primary Antibody",
        "CONFIRM anti-Desmin (DE-R-11) Primary Antibody",
        "CONFIRM anti-LMO2 (1A9-1) Mouse Monoclonal Primary Antibody",
        "CONFIRM anti-PAX5 (SP34) Rabbit Monoclonal Primary Antibody",
        "anti-CD30 (Ber-H2) Mouse Monoclonal Primary Antibody",
        "anti-Thyroid Transcription Factor-1 (SP141) Rabbit Monoclonal Primary Antibody",
        "FITC anti-Lambda Primary Antibody",
        "CONFIRM anti-Calretinin (SP65) Rabbit Monoclonal Primary Antibody",
        "Rabbit Monoclonal Negative Control Ig",
        "anti-Cytokeratin 10 (SP99) Rabbit Monoclonal Primary Antibody",
        "FITC anti-C1q Primary Antibody",
        "VENTANA PD-L1 (SP142) IHC Assay (export)",
        "CONFIRM anti-CD99 (O13) Mouse Monoclonal Primary Antibody",
        "CONFIRM anti-CD68 (KP-1) Primary Antibody",
        "CONFIRM anti-Topoisomerase IIa (JS5B4) Rabbit Monoclonal Primary Antibody",
        "anti-p504s (SP116)",
        "VENTANA PD-L1 (SP263) Rabbit Monoclonal Primary Antibody",
        "anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody",
        "NeuVision Blocking Reagent",
        "CONFIRM anti-Thyroid Transcription Factor-1 (8G7G3/1) Mouse Monoclonal Primary Antibody",
        "CONFIRM anti-Cytokeratin (AE1) Primary Antibody",
        "OptiView DAB IHC Detection Kit",
        "CONFIRM anti-Keratin (34?E12) Mouse Monoclonal Primary Antibody",
        "Anti-p53 (Bp53-11) Primary Antibody",
        "CONFIRM anti-ALK1 (ALK01) Primary Antibody",
        "anti-Glypican 3 (GC33) Mouse Monoclonal Primary Antibody",
        "anti-CD44 (SP37) Rabbit Monoclonal Primary Antibody",
        "CONFIRM anti-p53 (DO-7) Primary Antibody",
        "VENTANA anti-p120 catenin (98) Mouse Monoclonal Primary Antibody",
        "CONFIRM anti-CD79a (SP18) Rabbit Monoclonal Primary Antibody",
        "anti-EGFR L858R (SP125) Rabbit Monoclonal Primary Antibody",
        "CONFIRM anti-CD8 (SP57) Rabbit Monoclonal Primary Antibody",
        "anti-CD7 (SP94) Rabbit Monoclonal Primary Antibody",
        "VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody (export)",
        "FITC Anti-Fibrinogen Primary Antibody",
        "VENTANA Protease Neg Reagent Control-IVD",
        "VENTANA pan-TRK (EPR17341) Assay",
        "VENTANA CLDN18 [43-14A] Assay",
        "Ventana ROS1 (SP384) Rb Mono Primary Ab",
        "VENTANA MSLN (SP74) ASSAY",
        "anti-CD117 (EP10) Rabbit Monoclonal Primary Antibody",
        "CD117(EP10) Rabbit Monoclonal PAB",
        "VENTANA Red ISH DIG Detection Kit",
        "ECL-LC",
        "CONFIRM anti-MSH6 (44) Mouse Monoclonal",
        "RABBIT ANTI-DNP ANTIBODY",
        "VENTANA Silver ISH DNP Detection Kit",
        "VENTANA DLL3 (SP347) Assay",
        "IDH1 R132H (MRQ-67) CM Rabbit Monoclonal",
        "ATRX CM Rabbit Polyclonal Antibody",
        "VENTANA FGFR2b (FPR2-D) Assay 1",
        "PRAME (EPR20330) Rbt Mono PAB 50",
        "INSM1 (SP493) Rabbit Monoclonal Primary Antibody",
        "VENTANA HA Assay",
        "VENTANA Silver ISH BF Detection Kit",
        "VENTANA Magenta ISH DIG Detection Kit",
        "VENTANA anti-AREG (SP272) Rabbit Monoclonal Primary Antibody",
        "PRAME (EPR20330) Rbt Mono PAB 250",
        "TRPS1 (SP532) Rabbit Monoclonal Antibody",
        "CD68 (SP251v18) Rabbit Monoclonal Antibody",
        "CONFIRM anti-Ki-67 (30-9)",
        "VENTANA U6 DIG Probe",
        "VENTANA anti-EREG (SP326) Rabbit Monoclonal Primary Antibody",
        "VENTANA U6 BF Probe",
        "CD8 (SP239) Rabbit Monoclonal PAB",
        "ISH TSA Ancillary Kit",
        "CONFIRM MART-1/melan A (A103) 250 test",
        "PAX-8 (SP348) Rabbit Monoclonal Antibody",
        "p40 (SP225) Rabbit Monoclonal PAB",
        "VENTANA TROP2 (EPR20043) Rabbit Monoclonal Antibody",
        "VENTANA ANTI-P63 (4A4) 250",
        "VENTANA MTAP (SP530) Antibody",
        "Special Stains Congo Red Stain Core Kit",
        "Jones Stain Core Kit",
        "VENTANA HER2 (CAL27) Assay"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "9610529",
        "fei_number": "3002806560",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "ROCHE DIAGNOSTICS GMBH",
        "address_line_1": "NONNENWALD 2",
        "address_line_2": "",
        "city": "PENZBERG Bavaria",
        "state_code": "",
        "iso_country_code": "DE",
        "zip_code": "",
        "postal_code": "D-82377",
        "us_agent": {
          "name": "Brian Frazier",
          "business_name": "Roche Diagnostics Operations Inc",
          "bus_phone_area_code": "317",
          "bus_phone_num": "5214603",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "brian.frazier@roche.com",
          "address_line_1": "9115 Hague Rd",
          "address_line_2": "",
          "city": "Indianapolis",
          "state_code": "IN",
          "iso_country_code": "US",
          "zip_code": "46256",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Roche Diagnostics Operations Inc.",
          "owner_operator_number": "9039767",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "9115 Hague Road",
            "address_2": "",
            "city": "Indianapolis",
            "state_code": "IN",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "46250"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "NJT",
          "created_date": "2012-01-17",
          "owner_operator_number": "9039767",
          "exempt": "",
          "openfda": {
            "device_name": "Immunohistochemistry Reagents And Kits",
            "medical_specialty_description": "Hematology",
            "regulation_number": "864.1860",
            "device_class": "1"
          }
        }
      ]
    }
  ]
}