FDA.reportPublic FDA data

AU

Primary DI
15099590010065
Brand
AU
Company
Beckman Coulter, Inc.
Model
OSR6107
Device description
ALT
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CKANadh Oxidation/Nad Reduction, Alt/Sgpt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CKANadh Oxidation/Nad Reduction, Alt/SgptClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925339000OLYLMPUS ALANINE AMINOTRANSFERASE REAGENTOlympus Corp.1993-02-05CKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590010065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959001006515099590010065

GMDN Terms#

Term, Definition table
TermDefinition
Alanine aminotransferase (ALT) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of alanine aminotransferase (ALT) in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590799243MicroScanV5.03 PU11ED233522025-12-08
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
07613336130513Alanine Aminotransferase acc. to IFCC IIRoche Diagnostics GmbHCKA2024-01-26
00850053916021IDG/SANZAYIDG/SANZAY CorporationCKA2024-01-03
10673486001082ALT (SGPT) LIQUID REAGENT (KINETIC METHOD)TECO DIAGNOSTICSCKA2023-07-17
10673486001099ALT (SGPT) KINETIC METHOD TC MATRIX-240/480TECO DIAGNOSTICSCKA2023-07-17
10673486001105ALT (SGPT) REAGENT SET (UV-KINETIC METHOD)TECO DIAGNOSTICSCKA2023-07-17
10673486001112ALT (SGPT) REAGENT SET (UV-KINETIC METHOD)TECO DIAGNOSTICSCKA2023-07-17
06971674862031BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862048BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862055BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862062BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862079BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862086BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862093BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862109BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862116BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862123BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862130BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862147BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862154BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862161BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862178BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862185BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862192BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862208BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
00817302024647CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE AMINOTRANSFERASE REAGENT AU-240CAROLINA LIQUID CHEMISTRIES CORPORATIONCKA2022-10-18
00817302024111CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218CAROLINA LIQUID CHEMISTRIES CORPORATIONCKA2022-08-19