FDA.reportPublic FDA data

IDG/Sanzay

Primary DI
00850053916038
Brand
IDG/Sanzay
Company
IDG/SANZAY Corporation
Model
1
Catalog number
C065
Device description
For the quantitative determination of aspartate aminotransferase (AST) in human serum. The reagents are used in routine examination and monitoring of therapy and relapses.
Published
2024-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981650000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981650000AST/SGOT LIQUID REAGENT - KINETIC METHODTeco Diagnostics1998-06-29CIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850053916038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850053916038008500539160388500539160380850053916038

GMDN Terms#

Term, Definition table
TermDefinition
Aspartate aminotransferase (AST) isoenzyme IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of one or multiple aspartate aminotransferase (AST) isoenzymes in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Liter
Total Volume50Milliliter
Total Volume100Milliliter
Total Volume125Milliliter
Total Volume240Milliliter
Total Volume250Milliliter
Total Volume500Milliliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
948875013
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850053916212IDG/Sanzay1HCC12024-01-12
00850053916229IDG/Sanzay1HCC22024-01-12
00850053916007IDG/Sanzay1C0212023-12-18
00850053916205IDG/Sanzay1HC3012024-07-03
00850053916267IDG/Sanzay1QS012024-07-03
00850053916113IDG/Sanzay1C2432024-06-25
00850053916236IDG/Sanzay1QC012024-06-25
00850053916243IDG/Sanzay1QC022024-06-25
00850053916250IDG/Sanzay1QS31D2024-06-25
00850053916137IDG/Sanzay1C3432024-01-12
00850053916076IDG/Sanzay1C1052024-01-15
00850053916120IDG/Sanzay1C3212024-01-12
00850053916144IDG/Sanzay1C3912024-01-12
00850053916151IDG/Sanzay1C4032024-01-12
00850053916168IDG/Sanzay1C4132024-01-12
00850053916175IDG/Sanzay1C5012024-01-12
00850053916182IDG/Sanzay1HC1012024-01-12
00850053916199IDG/Sanzay1HC2012024-01-12
00850053916069IDG/Sanzay1C0952024-01-09
00850053916083IDG/Sanzay1C1232024-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336130537Aspartate Aminotransferase acc. to IFCC IIRoche Diagnostics GmbHCIT2024-01-12
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
00380740170066AlinityABBOTT IRELANDCIT2022-02-28