{
  "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": "2026-10-01",
    "results": {
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      "has_donation_id_number": "false",
      "mri_safety": "Labeling does not contain MRI Safety Information",
      "record_status": "Published",
      "is_labeled_as_nrl": "false",
      "is_rx": "false",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "Siemens Healthcare Diagnostics MULTISTIX PRO® 10LS Reagent Strips for Urinalysis include test pads for protein-high, protein-low, creatinine, blood, leukocytes, nitrite, glucose, ketone (acetoacetic acid), pH, and specific gravity.",
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      "has_serial_number": "false",
      "storage": [
        {
          "type": "Special Storage Condition, Specify",
          "special_conditions": "Do not store in direct sunlight."
        },
        {
          "type": "Storage Environment Temperature",
          "high": {
            "unit": "Degrees Celsius",
            "value": "30"
          },
          "low": {
            "unit": "Degrees Celsius",
            "value": "15"
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      ],
      "public_version_date": "2022-11-28",
      "sterilization": {
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        "is_sterilization_prior_use": "false"
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      "is_direct_marking_exempt": "false",
      "public_version_number": "7",
      "labeler_duns_number": "064608573",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00630414549255",
          "type": "Primary",
          "issuing_agency": "GS1"
        },
        {
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          "type": "Unit of Use",
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      "version_or_model_number": "10331147",
      "has_manufacturing_date": "false",
      "brand_name": "Multistix PRO® 10LS Reagent Strips",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "CEN",
          "name": "DYE-INDICATOR, PH (URINARY, NON-QUANT.)",
          "openfda": {
            "device_name": "Dye-Indicator, Ph (Urinary, Non-Quantitative)",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1550",
            "device_class": "1"
          }
        },
        {
          "code": "JFY",
          "name": "ENZYMATIC METHOD, CREATININE",
          "openfda": {
            "device_name": "Enzymatic Method, Creatinine",
            "medical_specialty_description": "Clinical Chemistry",
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          "code": "JIL",
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            "device_name": "Method, Enzymatic, Glucose (Urinary, Non-Quantitative)",
            "medical_specialty_description": "Clinical Chemistry",
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        },
        {
          "code": "JRE",
          "name": "REFRACTOMETER FOR CLINICAL USE",
          "openfda": {
            "device_name": "Refractometer For Clinical Use",
            "medical_specialty_description": "Clinical Chemistry",
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          "name": "TEST, URINE LEUKOCYTE",
          "openfda": {
            "device_name": "Test, Urine Leukocyte",
            "medical_specialty_description": "Hematology",
            "regulation_number": "864.7675",
            "device_class": "1"
          }
        },
        {
          "code": "JIN",
          "name": "NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)",
          "openfda": {
            "device_name": "Nitroprusside, Ketones (Urinary, Non-Quant.)",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1435",
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        },
        {
          "code": "CDM",
          "name": "DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)",
          "openfda": {
            "device_name": "Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1785",
            "device_class": "1"
          }
        },
        {
          "code": "JJB",
          "name": "AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)",
          "openfda": {
            "device_name": "Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)",
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            "regulation_number": "862.1115",
            "device_class": "1"
          }
        },
        {
          "code": "JMT",
          "name": "DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)",
          "openfda": {
            "device_name": "Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1510",
            "device_class": "1"
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        },
        {
          "code": "JIO",
          "name": "BLOOD, OCCULT, COLORIMETRIC, IN URINE",
          "openfda": {
            "device_name": "Blood, Occult, Colorimetric, In Urine",
            "medical_specialty_description": "Hematology",
            "regulation_number": "864.6550",
            "device_class": "2"
          }
        },
        {
          "code": "JIR",
          "name": "INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)",
          "openfda": {
            "device_name": "Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1645",
            "device_class": "1"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "K992257",
          "supplement_number": "000"
        }
      ],
      "device_count_in_base_package": "100",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "+1(877)229-3711",
          "email": "CONTACT@SIEMENS-HEALTHINEERS.COM"
        }
      ],
      "catalog_number": "A1554C16",
      "company_name": "Siemens Healthcare Diagnostics Inc.",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "54514",
          "name": "Multiple urine analyte IVD, kit, rapid colorimetric, clinical",
          "definition": "A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-09-24"
    }
  ]
}