FDA.reportPublic FDA data

AU

Primary DI
15099590010171
Brand
AU
Company
Beckman Coulter, Inc.
Model
OSR6119
Device description
Gamma-Glutamyltransferase (GGT)
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
JQBKinetic Method, Gamma-Glutamyl Transpeptidase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQBKinetic Method, Gamma-Glutamyl TranspeptidaseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590010171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959001017115099590010171

GMDN Terms#

Term, Definition table
TermDefinition
Gamma-glutamyltransferase (GGT) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of gamma glutamyltransferase (GGT) in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Premarket exempt
true
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
15099590799250MicroScanV5.03 PU11D233542025-12-08
15099590807146MicroScanV5.03 DD07ED336042025-12-08
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414628707Atellica CH Gamma-Glutamyl Transferse 2 (GGT_2)Siemens Healthcare Diagnostics Inc.JQB2024-02-02
00630414313382Atellica CH Gamma-Glutamyl Transferse 2 (GGT_2)Siemens Healthcare Diagnostics Inc.JQB2024-02-02
10673486001860Teco Diagnostics g-Glutamyl Transferase (GGT) Liquid Reagent Kit TC-Matrix-240TECO DIAGNOSTICSJQB2023-11-08
10673486001877Teco Diagnostics g-Glutamyl Transferase (GGT) Liquid Reagent Kit TC-Matrix-480TECO DIAGNOSTICSJQB2023-11-08
10673486001839Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate)TECO DIAGNOSTICSJQB2023-11-06
10673486001846Teco Diagnostics g-Glutamyl Transferase Reagent Set (Kinetic, Soluble Substrate)TECO DIAGNOSTICSJQB2023-11-06
10673486001853Teco Diagnostics g-Glutamyl Transferase (GGT) Liquid Reagent Set (Kinetic)TECO DIAGNOSTICSJQB2023-11-06
00811727016140Pointe GGT ReagentHORIBA INSTRUMENTS INCORPORATEDJQB2021-01-30
04015630916511gamma-Glutamyltransferase ver.2 Standardized against IFCC / SzaszRoche Diagnostics GmbHJQB2021-01-20
04015630925018gamma-Glutamyltransferase ver.2 Standardized against IFCC / SzaszRoche Diagnostics GmbHJQB2021-01-18
04015630926855gamma-Glutamyltransferase ver.2 Standardized against IFCC / SzaszRoche Diagnostics GmbHJQB2021-01-18
00842768014154Dimension® Flex® reagent cartridge GGTSiemens Healthcare Diagnostics Inc.JQB2020-09-24
00842768015229Dimension Vista® Flex® reagent cartridge GGTSiemens Healthcare Diagnostics Inc.JQB2020-09-24
03610230006993Yumizen C1200 GGTHORIBA ABX SASJQB2020-08-31
00811727015839Pointe GGT on BS480HORIBA INSTRUMENTS INCORPORATEDJQB2020-05-28
10758750004638VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JQB2020-04-18
07613336121252Gamma-Glutamyltransferase ver.2 Standardized against IFCC / SzaszRoche Diagnostics GmbHJQB2020-03-10
00628063401093GGT AssaySEKISUI DIAGNOSTICS, LLCJQB2018-09-24
00852169008133ClearChem Diagnostics Inc. Gamma-glutamyltransferase (GGT)CLEARCHEM DIAGNOSTICS INC.JQB2018-04-30
05060500091880Synermed®INFRARED LABORATORY SYSTEMS LLCJQB2017-02-28
00812137011978GGT Reagent SetCLINICAL DIAGNOSTIC SOLUTIONS, INC.JQB2016-10-12
15099590020095AUBeckman Coulter, Inc.JQB2016-09-24
EABA40000031Piccolo Liver Panel PlusABAXIS, INC.JQB2016-09-23
EABA40000061Piccolo General Chemistry 6ABAXIS, INC.JQB2016-09-23
EABA40000291Piccolo General Chemistry 13ABAXIS, INC.JQB2016-09-23
EABA40000351Piccolo BioChemistry Panel PlusABAXIS, INC.JQB2016-09-23
00657498000786Gamma-GT LiquiColor®STANBIO LABORATORY, L.P.JQB2016-09-23
00657498000793Gamma-GT LiquiColor®STANBIO LABORATORY, L.P.JQB2016-09-23
00657498001691Sirrus® Gamma-GT LiquiColor®STANBIO LABORATORY, L.P.JQB2016-09-23
05060500090876Synermed®INFRARED LABORATORY SYSTEMS LLCJQB2016-09-20