FDA.reportPublic FDA data

Yumizen C1200 GGT

Primary DI
03610230006993
Brand
Yumizen C1200 GGT
Company
HORIBA ABX SAS
Model
1300023846
Published
2020-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
03610230006993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03610230006993036102300069933610230006993

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
273647420
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03610230004883ABX PENTRA IMMUNO II CONTROL L/H12200016222016-08-23
03610230004623ABX CLEANER (0.5L)12109030112016-08-16
03610230009932ABX Micros 6013001465762026-01-23
03610230009444Yumizen H250013001021472024-11-29
03610230009451Yumizen H250013001021482024-11-29
03610230005774ABX PENTRA MICRO-ALB CAL12200019662016-09-05
03610230005781ABX PENTRA MICRO ALB CONTROL L/H12200019672016-08-16
03610230008232ABX Pentra Micro ALB 2 Cal13000325652017-07-07
03610230005187ABX PENTRA ALBUMIN CP12200016642016-08-23
03610230005767ABX PENTRA MICRO ALBUMIN CP12200019652016-08-16
03610230008225ABX Pentra Micro ALBUMIN 2 CP13000325632017-06-27
03610230007235Yumizen C1200 Albumin U/CSF13000238712020-09-14
03610230007464Yumizen C1200 Micro Alb U/CSF Cal Normal 1300023894 2020-09-07
03610230007891Yumizen C1200 U/CSF L1 Micro Alb Control 1300023948 2020-09-07
03610230007914Yumizen C1200 U/CSF L2 Micro Alb Control 1300023949 2020-09-07
03610230006825Yumizen C1200 Albumin13000237992020-05-06
03610230008966Yumizen P800013000333272025-07-07
03610230009611ABX Minocal530010030053001003002024-09-27
03610230008584BFTROL13000394052024-09-26
03610230009581ABX Minotrol 16530010031253001003122024-09-25

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
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
15099590010171AUBeckman Coulter, Inc.JQB2016-09-24
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