FDA.reportPublic FDA data

Gamma-GT LiquiColor®

Primary DI
00657498000786
Brand
Gamma-GT LiquiColor®
Company
STANBIO LABORATORY, L.P.
Model
2960-430
Catalog number
2960-430
Device description
For the Kinetic Quantitative Determination of γ-Glutamyl Transferase in Serum for Manual and/or Automated Procedures.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
00657498000786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00657498000786006574980007866574980007860657498000786

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18005315535stanbiolab@ekfdiagnostics.com

Regulatory Flags#

DUNS number
045361136
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
00657498001950Procalcitonin LiquiColor2300-0602300-0602017-06-26
00657498000434Albumin LiquiColor®0285-5000285-5002016-09-23
00657498001516Sirrus® Albumin LiquiColor®S0285-750S0285-7502016-09-23
00657498000847Glycated Serum Protein (GSP) LiquiColor®2350-0622350-0622016-09-23
00657498002179STAT-Site WB Dual Analyte Measurement System7000-0017000-0012019-11-18
00657498002193STAT-Site WB Blood Glucose Test Strips7010-0257010-0252019-11-18
00657498002209STAT-Site WB Blood Glucose Test Strips7010-0507010-0502019-11-18
00657498002216STAT-Site WB Blood Glucose Test Strips7010-1007010-1002019-11-18
00657498002230STAT-Site WB B-Ketone Test Strips7020-0257020-0252019-11-18
00657498002247STAT-Site WB B-Ketone Test Strips7020-0507020-0502019-11-18
00657498002254STAT-Site WB B-Ketone Test Strips7020-1007020-1002019-11-18
00657498002261Blood Glucose Control Solution7014-2047014-2042019-11-18
00657498002278B-Ketone Control Solution7024-2047024-2042019-11-18
00657498000427Acetaminophen Liquicolor®2400-0602400-0602016-09-23
00657498000441Alkaline Phosphatase LiquiColor®2900-4302900-4302016-09-23
00657498000458Alkaline Phosphatase LiquiColor®2900-5002900-5002016-09-23
00657498000489a-Amylase LiquiColor®2970-4302970-4302016-09-23
00657498000496AST/SGOT Liqui-UV®2920-4302920-4302016-09-23
00657498000502AST/SGOT Liqui-UV®2920-5002920-5002016-09-23
00657498000519B-Hydroxybutyrate LiquiColor®2440-0582440-0582016-09-23

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
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
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