FDA.reportPublic FDA data

JAS Diagnostics

Primary DI
00817274020883
Brand
JAS Diagnostics
Company
DREW SCIENTIFIC, INC.
Model
AST2-125U
Device description
AST LIQUID REAGENT (125mL) Unlabeld Vial
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00817274020883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817274020883008172740208838172740208830817274020883

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00817274022863Drew Scientific6106006106002021-08-20
00817274022832JAS DiagnosticsGLU2-125GLU2-1252018-11-06
00817274022849JAS DiagnosticsAMY2-BULAMY2-BUL2016-10-11
00817274022856JAS DiagnosticsHDL4-250HDL4-2502016-10-11
00817274022825JAS DiagnosticsMICS-10MICS-102018-10-03
00817274022818JAS DiagnosticsMICS-15MICS-152018-09-25
00817274022788JAS DiagnosticsMIA2-20MIA2-202018-07-24
00817274022795JAS DiagnosticsMIAC2-7MIAC2-72018-07-24
00817274022801JAS DiagnosticsMIAS-1MIAS-12018-07-24
00817274022764JAS Diagnostics, incMAG2-125MAG2-1252018-07-19
00817274022771JAS DiagnosticsAMY2-P1LAMY2-P1L2018-07-19
00817274020173Drew Scientific014-3502016-09-09
00817274020258Drew ScientificCA-30EX2016-09-09
00817274020272Drew ScientificEXA-1825N2016-09-09
00817274020289Drew ScientificEXA-25H2016-09-09
00817274020296Drew ScientificEXA-25L2016-09-09
00817274020302Drew ScientificEXA-25N2016-09-09
00817274020319Drew ScientificEXA-3262016-09-09
00817274020326Drew ScientificEXA-339+2016-09-09
00817274020333Drew ScientificEXA-3462016-09-09

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