FDA.reportPublic FDA data

Calibrator 1

Primary DI
04580262010307
Brand
Calibrator 1
Company
TOKYO BOEKI MEDISYS INC.
Model
20-27-0477
Catalog number
20-27-0477
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
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2
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
04580262010307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04580262010307045802620103074580262010307

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 Temperature10 Degrees Celsius30 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
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
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
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

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