BIOLIS 30i

Primary DI
04580262016002
Brand
BIOLIS 30i
Company
TOKYO BOEKI MEDISYS INC.
Model
60-01-0001
Catalog number
60-01-0001
Device description
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.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040958000
K103531000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040958000PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240Tokyo Boeki Medical System , Ltd.2005-02-15JJE
K103531000PRESTIGE 24I; BIOLIS 24I; MGC 240Tokyo Boeki Medisys, Inc.2011-12-01CFR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04580262016002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580262016002045802620160024580262016002

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratory, automatedAn electrically-powered laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, lipids and kidney, liver and/or cardiac function test analytes. The analyser typically requires analyte specific test kits or reagents, using one or more technologies which may include microfluidics, electrometry, spectrophotometry, fluorimetry, radiometry and/or chemiluminescence. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature1 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+81425872965kenji.takeuchi@tb-medisys.co.jp
+81425872965hiroshi.miyazato@tb-medisys.co.jp

Regulatory Flags#

DUNS number
696265656
Device count
1
Serial number
true
Manufacturing date on label
true

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Primary DI, Brand, Model table
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04580262046511ISE Cleaner (1%)50-27-078150-27-07812019-09-30
04580262046528ISE Cleaner (5%)50-27-078250-27-07822019-09-30
04580262046818Alkaline Washing Solution50-24-074750-24-07472019-09-30
04580262046825Acid Washing Solution50-24-074850-24-07482019-09-30
04580262010260Na (Sodium) Electrode20-27-047420-27-04742019-09-30
04580262010277K (Potassium) Electrode20-27-047520-27-04752019-09-30

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