AccessGUDID - DEVICE: BIOLIS 24i Premium (04580262020016)

GUDID

Device Identifier (DI) Information

Brand Name: BIOLIS 24i Premium
Version or Model: 23-01-0000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 23-01-0000
Company Name: TOKYO BOEKI MEDISYS INC.

Primary DI Number: 04580262020016
Issuing Agency: GS1
Commercial Distribution End Date: December 26, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 696265656 *Terms of Use

Device Description: Biolis 24i Premium 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 24i Premium with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, Biolis 24i Premium with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
56676	Multiple clinical chemistry analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technologies (e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence). Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040958	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0ff10e50-0d7a-4227-99e6-b1e41390a170
Public Version Date: February 01, 2024
Public Version Number: 8
DI Record Publish Date: September 23, 2016