FDA.reportPublic FDA data

JAS Diagnostics

Primary DI
00817274020913
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
AST2-BUP
Device description
AST PALS BULK (in 20 dry Liter bottles)
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00817274020913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274020913008172740209138172740209130817274020913

GMDN Terms#

Term, Definition table
TermDefinition
Aspartate aminotransferase (AST) isoenzyme IVD, controlA material which is used to verify the performance of a number of assays intended to be used for the qualitative and/or quantitative detection of one or multiple aspartate aminotransferase (AST) isoenzymes in a clinical specimen.

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
1-305-324-2300customersupport@erbadiagnostics.com

Regulatory Flags#

DUNS number
144968104
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817274020425Drew ScientificR12A24D-BUL2016-09-09
00817274021743JAS DiagnosticsA1CC1-0.52016-09-09
00817274021804JAS DiagnosticsLDH2-30R2U2016-09-12
00817274021811JAS DiagnosticsXL-LDH2-402016-09-12
00817274021828JAS DiagnosticsLDH2-120R1U2016-09-12
00817274021835JAS DiagnosticsLDH2-R1-BUL2016-09-12
00817274021842JAS DiagnosticsLDH2-R2-BUL2016-09-12
00817274021859JAS DiagnosticsDG-LDH2-1202016-09-12
00817274021866JAS DiagnosticsLDH2-1202016-09-12
00817274021873JAS DiagnosticsLDH2-1L2016-09-12
00817274020517Drew ScientificDSJ-9001-0012016-09-09
00817274020524DrewDSJ-9001-0212016-09-09
00817274021491JAS DiagnosticsBAS-9001-1812016-09-09
00817274022214JAS DiagnosticsTA1039802016-09-12
00817274022221JAS DiagnosticsTA1035772016-09-12
00817274020692JAS DiagnosticsALP2-1L2016-09-09
00817274020708JAS DiagnosticsXL-ALP2-402016-09-09
00817274020715JAS DiagnosticsALP2-120R1U2016-09-09
00817274020722JAS DiagnosticsALP2-30R2U2016-09-09
00817274020739JAS DiagnosticsALT2-P1L2016-09-09

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