BIOLIS 50i

Primary DI
04580262040014
Brand
BIOLIS 50i
Company
TOKYO BOEKI MEDISYS INC.
Model
50-01-0000
Catalog number
50-01-0000
Device description
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.
Published
2016-09-23
Public version status
Update
Distribution status
Not 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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04580262040014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580262040014045802620400144580262040014

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
Storage 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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04580262010345Diluent for Urine20-27-048220-27-04822019-09-30
04580262010314Calibrator 220-27-047820-27-04782023-12-18
04580262010321Cleaning Solution20-27-047920-27-04792023-12-18
04580262040076Calibrator 230-27-090530-27-09052019-09-30
04580262049802IMMTOX 27060-01-900160-01-90012021-11-26
04580262049819DZ-Lite c27060-01-900260-01-90022021-11-26
04580262049826MyeLyte Touch60-01-900360-01-90032021-11-26
04580262010208Alkaline Washing SolutionSP2208SP22082019-09-30
04580262010222Acid Washing SolutionSP2209SP22092019-09-30
04580262010291Reference Electrode20-27-047320-27-04732019-09-30
04580262010307Calibrator 120-27-047720-27-04772019-09-30
04580262010338Urine Calibrator Set20-27-048020-27-04802019-09-30
04580262010352Dialysis Calibrator20-27-048320-27-04832019-09-30
04580262016019Calibrator SET A, B60-22-026360-22-02632019-09-30
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
04580262016002BIOLIS 30i60-01-000160-01-00012016-09-23
04580262010260Na (Sodium) Electrode20-27-047420-27-04742019-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810053950074NOVEOS Sesame Seed, Sesamum indicumHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950104NOVEOS Soybean, Glycine maxHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950111NOVEOS Hazelnut, Corylus avellanaHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950135NOVEOS Almond, Amygdalus communisHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950296NOVEOS Bos d 8 Casein, MilkHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950319NOVEOS Lobster, Homarus gammarusHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950449NOVEOS Ara h 8 PR-10, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950456NOVEOS Ara h 1, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950463NOVEOS Ara h 2, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950494NOVEOS Ara h 6, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879023770NOVEOS Sesame Seed, Sesamum indicumHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024203NOVEOS Lobster, Homarus gammarusHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024333NOVEOS Ara h 1, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024470NOVEOS Bos d 8 Casein, MilkHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879024982NOVEOS Ara h 2, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879025323NOVEOS Ara h 8 PR-10, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879025354NOVEOS Soybean, Glycine maxHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879025378NOVEOS Ara h 6, PeanutHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879027341NOVEOS Hazelnut, Corylus avellanaHYCOR BIOMEDICAL LLCJJE2026-07-29
00816879027969NOVEOS Almond, Amygdalus communisHYCOR BIOMEDICAL LLCJJE2026-07-29
00810053950128NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950203NOVEOS Coconut, Cocos nuciferaHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950210NOVEOS Tuna, Thunnus sp.HYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950227NOVEOS Salmon, Salmo salarHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950265NOVEOS Egg Yolk, Gallus gallusHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950340NOVEOS Pecan Nut, Carya illinoensisHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950364NOVEOS Pistachio Nut, Pistacia veraHYCOR BIOMEDICAL LLCJJE2026-05-29
00810053950418NOVEOS Oyster, Ostrea edulisHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879023794NOVEOS Brazil Nut, Bertholletia excelsaHYCOR BIOMEDICAL LLCJJE2026-05-29
00816879023824NOVEOS Tuna, Thunnus sp.HYCOR BIOMEDICAL LLCJJE2026-05-29