FDA.reportPublic FDA data

Calibrator 2

Primary DI
04580262040076
Brand
Calibrator 2
Company
TOKYO BOEKI MEDISYS INC.
Model
30-27-0905
Catalog number
30-27-0905
Published
2019-09-30
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
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

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
04580262040076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580262040076045802620400764580262040076

GMDN Terms#

Term, Definition table
TermDefinition
Multiple clinical chemistry analyser IVD, laboratoryAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
696265656
Device count
1
Lot or batch
true
Expiration date on label
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
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
04580262010277K (Potassium) Electrode20-27-047520-27-04752019-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850083817022Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
00850083817039Solomon Commutable Quality MaterialsSolomon Park Research Laboratories, Inc.JIX2026-04-06
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSJIX2025-05-28
00850033167184Smartest Persona II Multi Blood Glucose Monitoring SystemGlobalmed Holdings, LLCJIX2024-12-02
00630414615097Atellica CH Billirubin Calibrator (BILI CAL)Siemens Healthcare Diagnostics Inc.JIX2024-04-03
00630414611051Atellica CH Prot2 CALSiemens Healthcare Diagnostics Inc.JIX2024-02-02
00852676007063Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2023-08-09
08430793040518Aptiva® Celiac Disease IgG CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
08430793040570Aptiva® Celiac Disease IgA CalibratorsINOVA DIAGNOSTICS, INC.JIX2022-05-27
14987481102924Multi Calibrator LipidsFUJIFILM WAKO PURE CHEMICAL CORPORATIONJIX2020-10-23
00380740161378ARCHITECTAbbott GmbHJIX2020-09-18
00817302023213Carolina Liquid Chemistries Corp. ISE Internal Standard Solution DT88820CAROLINA LIQUID CHEMISTRIES CORPORATIONJIX2020-05-08
00852676007780Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JIX2020-03-28
00630414284972N Rheumatology Standard SLSiemens Healthcare Diagnostics Products GmbHJIX2020-02-14
04250317522450Plasma Calibrator Set Chromsystems Instruments + Chemicals GmbHJIX2019-07-26
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04250317535139Plasma Calibration SetChromsystems Instruments + Chemicals GmbHJIX2019-07-26
04250317542755Urine Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
04250317542809Plasma Calibration StandardChromsystems Instruments + Chemicals GmbHJIX2019-03-22
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