Biolis 30i 60-01-0001

GUDID 04580262016002

Biolis 30i is discrete photometric clinical chemistry analyzer. The device is intended to duplicate manual analytical procedures by automating various steps such as pipetting, heating, measuring color intensity, and reporting results. The device is intended to be used with certain materials to measure various analytes of diagnostic interest including glucose. An optional Ion Selective Electrode Module is intended to measure sodium, potassium and chloride. Biolis 30i with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, Biolis 30i with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.

TOKYO BOEKI MEDISYS INC.

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• Primary Device ID: 04580262016002
• NIH Device Record Key: 7984b5f1-17f6-4ccc-a69b-479e98113f8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biolis 30i
• Version Model Number: 60-01-0001
• Catalog Number: 60-01-0001
• Company DUNS: 696265656
• Company Name: TOKYO BOEKI MEDISYS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
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• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
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• Email: kenji.takeuchi@tb-medisys.co.jp
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• Phone: +81425872965
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• Email: kenji.takeuchi@tb-medisys.co.jp
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• Email: kenji.takeuchi@tb-medisys.co.jp
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• Email: kenji.takeuchi@tb-medisys.co.jp
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• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
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• Email: kenji.takeuchi@tb-medisys.co.jp
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• Email: kenji.takeuchi@tb-medisys.co.jp
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• Email: kenji.takeuchi@tb-medisys.co.jp
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• Email: kenji.takeuchi@tb-medisys.co.jp
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• Email: kenji.takeuchi@tb-medisys.co.jp
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• Email: kenji.takeuchi@tb-medisys.co.jp
• Phone: +81425872965
• Email: kenji.takeuchi@tb-medisys.co.jp
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• Email: kenji.takeuchi@tb-medisys.co.jp
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• Email: hiroshi.miyazato@tb-medisys.co.jp
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Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 1 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04580262016002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040958
• Premarket Notification: K103531

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-09-23

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