FDA.reportPublic FDA data

GAMMA-GLUTAMYLTRANSERASE (GGT)

Primary DI
05055273215502
Brand
GAMMA-GLUTAMYLTRANSERASE (GGT)
Company
RANDOX LABORATORIES LIMITED
Model
GT8146
Catalog number
GT8146
Device description
A Gamma GT test system is a device intended for the quantitative in vitro determination of L Gamma Glutamyltransferase (GGT) activity in serum and plasma.
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273215502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273215502050552732155025055273215502

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.

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
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273218985ConcizuTrace™ ELISACZM10591CZM105912025-05-30
05055273210101Liquid Immunoassay Control – Level 1 (IA CONTROL 1)LIA5142LIA51422025-03-24
05055273210118LIQUID IMMUNOASSAY CONTROL - LEVEL 2 (IA CONTROL 2)LIA5143LIA51432025-03-24
05055273210125LIQUID IMMUNOASSAY CONTROL - LEVEL 3 (IA CONTROL 3)LIA5144LIA51442025-03-24
05055273219814PTH CONTROL LEVEL 1 (PTH CONTROL 1)PTH10608PTH106082025-03-24
05055273219821PTH CONTROL LEVEL 2 (PTH CONTROL 2)PTH10609PTH106092025-03-24
05055273219838PTH CONTROL LEVEL 3 (PTH CONTROL 3)PTH10610PTH106102025-03-24
05055273219043LIQUID CARDIAC CONTROL 1CQ10534CQ105342025-03-21
05055273219050LIQUID CARDIAC CONTROL 2CQ10535CQ105352025-03-21
05055273219067LIQUID CARDIAC CONTROL 3CQ10536CQ105362025-03-21
05055273219128LIQUID CARDIAC CONTROL LEVEL 1 (LIQUID CARDIAC CONTROL 1)CQ10616CQ106162025-03-21
05055273219135LIQUID CARDIAC CONTROL LEVEL 2 (LIQUID CARDIAC CONTROL 2)CQ10617CQ106172025-03-21
05055273219142LIQUID CARDIAC CONTROL LEVEL 3 (LIQUID CARDIAC CONTROL 3)CQ10618CQ106182025-03-21
05055273219159Assayed Liquid Chemistry Control Level 1 (ASY LIQ CHEM CONTROL 1)LAL10565LAL105652025-03-21
05055273219166Assayed Liquid Chemistry Control Level 2 (ASY LIQ CHEM CONTROL 2)LAN105662025-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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05055273203462GAMMA-GLUTAMYLTRANSERASE (GGT)RANDOX LABORATORIES LIMITEDJPZ2022-09-22
05055273208801GAMMA-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 GmbH & Co. KGJPZ2020-02-29
00380740161729ARCHITECTAbbott GmbH & Co. KGJPZ2020-02-29
05055273203455GGTRANDOX LABORATORIES LIMITEDJPZ2018-12-24