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.

Multiple clinical chemistry analyser IVD, laboratory, automated
Primary Device ID04580262016002
NIH Device Record Key7984b5f1-17f6-4ccc-a69b-479e98113f8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiolis 30i
Version Model Number60-01-0001
Catalog Number60-01-0001
Company DUNS696265656
Company NameTOKYO BOEKI MEDISYS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailkenji.takeuchi@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp
Phone+81425872965
Emailhiroshi.miyazato@tb-medisys.co.jp

Operating and Storage Conditions

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 1 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104580262016002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-23
Device Publish Date2016-09-23

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