FDA.reportPublic FDA data

ASPARTATE AMINOTRANSFERASE (AST)

Primary DI
05055273208238
Brand
ASPARTATE AMINOTRANSFERASE (AST)
Company
RANDOX LABORATORIES LIMITED
Model
AS8005
Published
2019-06-03
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
CITNadh Oxidation/Nad Reduction, Ast/Sgot

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CITNadh Oxidation/Nad Reduction, Ast/SgotClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273208238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273208238050552732082385055273208238

GMDN Terms#

Term, Definition table
TermDefinition
Total aspartate aminotransferase (AST) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of total aspartate aminotransferase (AST) in a clinical specimen, using an enzyme spectrophotometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
227530649
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055273200560AMYAY1580AY15802016-09-09
05055273200577AMYAY1582AY15822016-09-09
05055273200584AMYAY2811AY28112016-09-09
05055273200591P AMYAY2862AY28622016-09-09
05055273200607AMYAY3805AY38052016-09-09
05055273200614P AMYAY3855AY38552016-09-09
05055273200645AMYAY7931AY79312016-09-09
05055273200652AMYAY7932AY79322016-09-09
05055273200669P AMYAY7934AY79342016-09-09
05055273200676AMYAY9707AY97072016-09-09
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
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336130537Aspartate Aminotransferase acc. to IFCC IIRoche Diagnostics GmbHCIT2024-01-12
00850053916038IDG/SanzayIDG/SANZAY CorporationCIT2024-01-05
06971674861850BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861867BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861874BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861881BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861898BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861904BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861911BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861928BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861935BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861942BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861959BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861966BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861973BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861980BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674861997BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674862000BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674862017BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
06971674862024BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CIT2023-07-21
10673486001150AST/SGOT LIQUID REAGENT (KINETIC METHOD)TECO DIAGNOSTICSCIT2023-07-20
10673486001167AST (SGOT) KINETIC METHOD TC MATRIX-240/480TECO DIAGNOSTICSCIT2023-07-20
10673486001174AST (SGOT) REAGENT SET (UV-KINETIC METHOD)TECO DIAGNOSTICSCIT2023-07-20
10673486001181AST (SGOT) REAGENT SET (UV-KINETIC METHOD)TECO DIAGNOSTICSCIT2023-07-20
00380740155735ARCHITECTABBOTT IRELANDCIT2022-06-14
00380740155759ARCHITECTABBOTT IRELANDCIT2022-06-14
00380740158057AlinityABBOTT IRELANDCIT2022-06-14
00380740158064AlinityABBOTT IRELANDCIT2022-06-14
00380740170011ARCHITECTABBOTT IRELANDCIT2022-05-24
00380740170028ARCHITECTABBOTT IRELANDCIT2022-05-24