BIOLIS 24i Premium

FDA UDI

Class I (US FDA UDI)

by Tokyo Boeki Medisys Inc.

Identity

Trade Name: BIOLIS 24i Premium FDA UDI
Generic Name: Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 23-01-0000 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: 23-01-0000 FDA UDI
Primary DI / UDI-DI: 04580262020016 FDA UDI
510(k) Number: K040958 FDA UDI
FDA Product Code: JJE FDA UDI
GMDN Term: Multiple clinical chemistry analyser IVD, laboratory FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.2160 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

BIOLIS 24i Premium by Tokyo Boeki Medisys Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K040958 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Tokyo Boeki Medisys Inc.

Sources (1)

FDA UDI 0ff10e50-0d7a-4227-99e6-b1e41390a170 38 fields · synced Jun 8, 2026