{
  "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": "2026-10-26",
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        "REDxFLOQ® HSV1 and HSV2 Swab Positive Control",
        "REDx TV/NG FQr/MG MLr Positive Control",
        "REDx Sapovirus Positive Control",
        "REDxFLOQ® HPV 16/18/45 Swab Positive Control",
        "REDx Enteric Bacterial Panel 1 Positive Control",
        "REDxFLOQ® Campylobacter jejuni Swab Positive Control",
        "REDxFLOQ® HPV 16 Swab Positive Control",
        "REDxFLOQ® HSV2 and VZV Swab Positive Control",
        "REDx Astrovirus Positive Control",
        "REDx Cryptosporidium parvum Positive Control (MDx)",
        "REDxFLOQ® Shiga toxin-producing E. coli Swab Positive Control",
        "REDx Salmonella enteritidis Positive Control",
        "REDx Enterotoxigenic E. coli Positive Control",
        "EDxFLOQ® Entamoeba histolytica Swab Positive Control",
        "REDx Respiratory Viral Panel 1 Positive Control",
        "REDxFLOQ® HPV 16 Swab Positive Control (Normalized Viral Load)",
        "REDxFLOQ® Vibrio parahaemolyticus Swab Positive Control",
        "REDxFLOQ® Chlamydia trachomatis & Neisseria gonorrhoeae Swab Positive Control",
        "REDx Plesiomonas shigelloides Positive Control",
        "REDxFLOQ® Trichomonas vaginalis Swab Positive Control",
        "REDxFLOQ® HPV 31/33/66 Swab Positive Control",
        "REDx Enteric Viral Panel Positive Control",
        "REDx Rhinovirus Positive Control",
        "REDxFLOQ® Monkeypox West African Swab Positive Control",
        "REDxFLOQ® Enteric Viral Panel Swab Positive Control",
        "REDxFLOQ® CT/NG/TV/MG Swab Positive Control",
        "REDx Seasonal Coronavirus NL63 Positive Control",
        "REDxFLOQ® Giardia lamblia Swab Positive Control (MDx)",
        "REDxFLOQ® Trichomonas vaginalis & Mycoplasma genitalium Swab Positive Control",
        "REDxFLOQ® Adenovirus F40/41 Swab Positive Control",
        "REDxFLOQ® HPV 45 Swab Positive Control (Normalized Viral Load)",
        "REDxFLOQ® Rhinovirus Swab Positive Control",
        "REDxFLOQ® Human Metapneumovirus Swab Positive Control",
        "REDxFLOQ® M. genitalium A2058T Swab Positive Control",
        "REDx HPV 66 Positive Control",
        "REDx HPV 18 Positive Control",
        "REDxFLOQ® SARS-CoV-2 P.1 Swab Positive Control",
        "REDx HPV 31 Positive Control",
        "REDx HPV 31/33/66 Positive Control",
        "REDx Giardia lamblia Positive Control",
        "REDxFLOQ® M. genitalium A2058G Swab Positive Control",
        "REDx Chlamydia trachomatis Positive Control",
        "REDx SARS-CoV-2 Positive Control",
        "REDxFLOQ® SARS-CoV-2/Flu A&B/ RSV Swab Positive Control",
        "REDx HPV 39 Positive Control",
        "REDxFLOQ® SARS-CoV-2 B.1.351 Swab Positive Control",
        "REDx HPV 16 Positive Control",
        "REDx RSV Positive Control",
        "REDxFLOQ® Respiratory NAAT Influenza B and RSV Swab Positive Control",
        "REDxFLOQ® Influenza B Swab Positive Control",
        "REDx Cryptosporidium parvum Positive Control",
        "REDx HPV 45 Positive Control",
        "REDxFLOQ® Group A Streptococcus Swab Positive Control",
        "REDxFLOQ® SARS-CoV-2 Swab Positive Control",
        "REDxFLOQ® Respiratory Swab Negative Control",
        "REDxFLOQ® Respiratory NAAT Influenza B and SARS-CoV-2 Swab Positive Control",
        "REDx HSV2 Positive Control",
        "REDxFLOQ® M. genitalium A2059C Swab Positive Control",
        "REDxFLOQ® Respiratory NAAT Influenza B Swab Positive Control",
        "REDx HPV 33 Positive Control",
        "REDxFLOQ® Respiratory NAAT Influenza A Swab Positive Control",
        "REDx FLOQ® SARS-CoV-2 Swab Negative Control",
        "REDxFLOQ® Respiratory NAAT Influenza A and RSV Swab Positive Control",
        "REDx Influenza A and Influenza B Positive Control",
        "REDxFLOQ® Respiratory NAAT RSV Swab Positive Control",
        "REDx Chlamydia trachomatis Positive Control (MDx)",
        "REDxFLOQ® Respiratory NAAT Influenza A and SARS-CoV-2 Swab Positive Control",
        "REDx hr-HPV Negative Control",
        "REDxFLOQ® Group A Streptococcus Swab Positive Control (M2)",
        "REDx Trichomonas vaginalis Positive Control",
        "REDxFLOQ® CT/NG/TV Swab Positive Control",
        "REDx HPV 39/51/52 Positive Control",
        "REDx Influenza B Positive Control",
        "REDxFLOQ® HPV 45 Swab Positive Control",
        "REDx HPV 51 Positive Control",
        "REDxFLOQ® Respiratory NAAT Influenza A and Influenza B Swab Positive Control",
        "REDx HPV 16/18/45 Positive Control",
        "REDxFLOQ® HSV1 Swab Positive Control",
        "REDx STI Negative Control",
        "REDxFLOQ® Enteric Parasite Panel Swab Positive Control",
        "REDxFLOQ® Mycoplasma genitalium Swab Positive Control",
        "REDx CT/NG/MG FQr & MLr Positive Control",
        "REDxFLOQ® SARS-CoV-2 B.1.1.529 Swab Positive Control",
        "REDxFLOQ® HPV Swab Negative Control",
        "REDxFLOQ® Clostridium difficile Swab Positive Control",
        "REDx Shigella sonnei Positive Control",
        "REDx HPV 52 Positive Control",
        "REDx Rotavirus Positive Control",
        "REDx Enteric Parasite Panel Positive Control",
        "REDxFLOQ® Salmonella enteritidis Swab Positive Control",
        "REDxFLOQ® Respiratory NAAT RSV Swab Positive Control (Low Level)",
        "REDxFLOQ® HSV1/HSV2/VZV Swab Positive Control",
        "REDxFLOQ® Chlamydia trachomatis Swab Positive Control",
        "REDxFLOQ® HPV 18 Swab Positive Control (Normalized Viral Load)",
        "REDxFLOQ® H. pylori Swab Positive Control",
        "REDxFLOQ® Enterotoxigenic E. coli Swab Positive Control",
        "REDxFLOQ® HSV1 and T. pallidum Swab Positive Control",
        "REDxFLOQ® SARS-CoV-2 B.1.1.7 Swab Positive Control",
        "REDx Influenza A Positive Control",
        "REDxFLOQ® Norovirus GII Ag Swab Positive Control",
        "REDxFLOQ® T. pallidum and VZV Swab Positive Control",
        "REDxFLOQ® HSV1&2/VZV/T. pallidum Swab Positive Control",
        "REDx HSV1 Positive Control",
        "REDxFLOQ® HPV 39/51/52 Swab Positive Control",
        "REDxFLOQ® Plesiomonas shigelloides Swab Positive Control",
        "REDxFLOQ® Cryptosporidium parvum Swab Positive Control (MDx)",
        "REDxFLOQ® M. genitalium A2058C Swab Positive Control",
        "REDxFLOQ® Yersinia enterocolitica Swab Positive Control",
        "REDxFLOQ® Norovirus GI Ag Swab Positive Control",
        "REDxFLOQ® Rotavirus Swab Positive Control (MDx)",
        "REDx Adenovirus F40/41 Positive Control",
        "REDxFLOQ® M. genitalium A2059G Swab Positive Control",
        "REDxFLOQ® Astrovirus Swab Positive Control",
        "REDx Chlamydia trachomatis and Neisseria gonorrhoeae Positive Control",
        "REDx MG Positive Control",
        "REDxFLOQ® HSV1 and VZV Swab Positive Control",
        "REDx SARS-CoV-2 Negative Control",
        "REDxFLOQ® SARS-CoV-2 Ag Swab Positive Control",
        "REDxFLOQ® Treponema pallidum Swab Positive Control",
        "REDxFLOQ® VZV Swab Positive Control",
        "REDx Norovirus GI Positive Control",
        "REDxFLOQ® Sapovirus Swab Positive Control",
        "REDxFLOQ® HSV2 Swab Positive Control",
        "REDxFLOQ® HSV2 and T. pallidum Swab Positive Control",
        "REDxFLOQ® Enteric Bacterial Panel 2 Swab Positive Control",
        "REDx FLOQ® RSV Swab Positive Control",
        "REDxFLOQ® Influenza A Swab Positive Control",
        "REDxFLOQ® Shigella sonnei Swab Positive Control",
        "REDxFLOQ® SARS-CoV-2 B.1.617 Swab Positive Control",
        "REDx Shiga toxin-producing E. coli Positive Control",
        "REDx Vibrio parahaemolyticus Positive Control",
        "REDxFLOQ® Enteric Bacterial Panel 1 Swab Positive Control",
        "REDx Enterovirus Positive Control",
        "REDx Rotavirus Positive Control (MDx)",
        "REDx Neisseria gonorrhoeae Positive Control",
        "REDx Cryptosporidium parvum and Giardia lamblia Positive Control",
        "REDxFLOQ® Respiratory NAAT RSV and SARS-CoV-2 Swab Positive Control",
        "REDxFLOQ® Neisseria gonorrhoeae Swab Positive Control",
        "REDxFLOQ® Norovirus GI Swab Positive Control",
        "REDxFLOQ® Group A Streptococcus Swab Positive Control (M1)",
        "REDxFLOQ® Enterovirus Swab Positive Control",
        "REDxFLOQ® Respiratory NAAT Influenza B Swab Positive Control (Low Level)",
        "REDxFLOQ® Respiratory NAAT Influenza A Swab Positive Control (Low Level)",
        "REDxFLOQ® HPV 18 Swab Positive Control",
        "REDx Enteric Bacterial Panel 2 Positive Control",
        "REDx Entamoeba histolytica Positive Control",
        "REDx Clostridium difficile Positive Control",
        "REDxFLOQ® Bacterial Vaginosis Panel Swab Positive Control",
        "REDx Norovirus GII Positive Control",
        "REDx Yersinia enterocolitica Positive Control",
        "REDx Human Metapneumovirus Positive Control",
        "REDx Giardia lamblia Positive Control (MDx)",
        "REDxFLOQ® Seasonal Coronavirus NL63 Swab Positive Control",
        "REDxFLOQ® HPV 31/33/39 Swab Positive Control (Normalized Viral Load)",
        "REDxFLOQ® Respiratory Viral Panel 1 Swab Positive Control",
        "REDx Campylobacter jejuni Positive Control",
        "REDxFLOQ® Candida Panel Swab Positive Control",
        "REDxFLOQ® Norovirus GII Swab Positive Control"
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      "establishment_type": [
        "Export Device to the United States But Perform No Other Operation on Device",
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3007652384",
        "fei_number": "3007652384",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "MICROBIX",
        "address_line_1": "265 Watline Avenue",
        "address_line_2": "",
        "city": "Mississauga Ontario",
        "state_code": "",
        "iso_country_code": "CA",
        "zip_code": "",
        "postal_code": "L4Z 1P3",
        "us_agent": {
          "name": "Jamie Harris",
          "business_name": "ICON Clinical Research",
          "bus_phone_area_code": "661",
          "bus_phone_num": "4252391",
          "bus_phone_extn": "",
          "fax_area_code": "",
          "fax_num": "",
          "email_address": "jamie.harris@iconplc.com",
          "address_line_1": "731 Arbor Way Ste 100",
          "address_line_2": "",
          "city": "Blue Bell",
          "state_code": "PA",
          "iso_country_code": "US",
          "zip_code": "19422",
          "postal_code": ""
        },
        "owner_operator": {
          "firm_name": "Microbix",
          "owner_operator_number": "10061165",
          "official_correspondent": {
            "first_name": "Bo",
            "middle_initial": "",
            "last_name": "Hollas",
            "subaccount_company_name": "",
            "phone_number": "1-905-3618910-x"
          },
          "contact_address": {
            "address_1": "265 Watline Avenue",
            "address_2": "",
            "city": "Mississauga",
            "state_code": "CA-ON",
            "state_province": "Ontario",
            "iso_country_code": "CA",
            "postal_code": "L4Z 1P3"
          }
        }
      },
      "pma_number": "",
      "k_number": "",
      "products": [
        {
          "product_code": "JJX",
          "created_date": "2019-09-03",
          "owner_operator_number": "10061165",
          "exempt": "",
          "openfda": {
            "device_name": "Single (Specified) Analyte Controls (Assayed And Unassayed)",
            "medical_specialty_description": "Clinical Chemistry",
            "regulation_number": "862.1660",
            "device_class": "1"
          }
        }
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}