BIOLIS 50i - BIOLIS 50i Superior is discrete photometric - TOKYO BOEKI MEDISYS INC.

Duns Number:696265656

Device Description: BIOLIS 50i Superior is discrete photometric clinical chemistry analyzer. The device is int BIOLIS 50i Superior 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 50i Superior with glucose hexokinase assay are intended to measure glucose quantitatively in human serum. Additionally, BIOLIS 50i Superior with Ion-Selective Elective modules additionally measure the concentration of the electrolytes, sodium, potassium and chloride in serum, using indirect potentiometry.

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More Product Details

Catalog Number

50-01-0000

Brand Name

BIOLIS 50i

Version/Model Number

50-01-0000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K040958

Product Code Details

Product Code

JJE

Product Code Name

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

Device Record Status

Public Device Record Key

8a06d344-add2-4911-92d7-578252f5b41f

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TOKYO BOEKI MEDISYS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22