FDA.reportPublic FDA data

Synchron

Primary DI
15099590233044
Brand
Synchron
Company
Beckman Coulter, Inc.
Model
442650
Catalog number
442650
Device description
Gamma-Glutamyl Transferase Reagent (γ-GT 2 x 200)
Published
2016-08-24
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
JPZColorimetric Method, Gamma-Glutamyl Transpeptidase

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971333000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971333000SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYDBeckman Instruments, Inc.1997-05-23JIX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15099590233044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1509959023304415099590233044

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
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
06971674861676BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861683BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861713BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861720BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861737BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861744BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861768BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861799BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861805BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861812BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861829BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861836BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861843BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861690BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-20
06971674861706BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-20
06971674861751BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-20
06971674861775BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-20
06971674861782BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-20
05055273203462GAMMA-GLUTAMYLTRANSERASE (GGT)RANDOX LABORATORIES LIMITEDJPZ2022-09-22
05055273208801GAMMA-GLUTAMYLTRANSERASE (GGT)RANDOX LABORATORIES LIMITEDJPZ2022-09-22
05055273215502GAMMA-GLUTAMYLTRANSERASE (GGT)RANDOX LABORATORIES LIMITEDJPZ2022-09-22
00817302024159CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT BL209CAROLINA LIQUID CHEMISTRIES CORPORATIONJPZ2022-08-19
00817302024395CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT DT209CAROLINA LIQUID CHEMISTRIES CORPORATIONJPZ2022-08-19
00817302024531CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT ST209CAROLINA LIQUID CHEMISTRIES CORPORATIONJPZ2022-08-19
00380740155308AlinityABBOTT IRELANDJPZ2022-06-14
00380740155315AlinityABBOTT IRELANDJPZ2022-06-14
00380740155896ARCHITECTABBOTT IRELANDJPZ2022-06-14
00380740155902ARCHITECTABBOTT IRELANDJPZ2022-06-14
00380740161712ARCHITECTAbbott GmbHJPZ2020-02-29
00380740161729ARCHITECTAbbott GmbHJPZ2020-02-29