FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740170035
Brand
ARCHITECT
Company
ABBOTT IRELAND
Model
08L9224
Catalog number
08L9224
Device description
Activated Alanine Aminotransferase 2750 Tests
Published
2022-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CKANADH OXIDATION/NAD REDUCTION, ALT/SGPT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CKANadh Oxidation/Nad Reduction, Alt/SgptClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740170035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740170035003807401700353807401700350380740170035

GMDN Terms#

Term, Definition table
TermDefinition
Alanine aminotransferase (ALT) 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 quantitative measurement of alanine aminotransferase (ALT) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature030 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
989964119
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
00380740155322Alinity04T992004T99202025-12-19
00380740155339Alinity04T993004T99302025-12-19
00380740155612Alinity04T852004T85202025-12-19
00380740156718ARCHITECT04S892004S89202025-12-19
00380740195236ARCHITECT04T032004T03202025-12-19
00380740195243ARCHITECT04T033004T03302025-12-19
00380740106003ARCHITECT7K78-3507K78352025-12-12
00380740180713Alinity04U002004U00202025-10-24
00380740180720ARCHITECT04T042004T04202025-10-24
00380740204020ARCHITECT04T040104T04012025-10-24
00380740204037Alinity04U000104U00012025-10-24
00380740130572Alinity07P944007P94402020-07-03
00380740014346ARCHITECT7K64-5007K64502016-09-09
00380740155285Alinity04T822004T82202024-08-15
00380740155292Alinity04T823004T82302024-08-15
00380740155346Alinity04U302004U30202024-08-15
00380740155353Alinity04U303004U30302024-08-15
00380740155483ARCHITECT04U452004U45202024-08-15
00380740155490ARCHITECT04U453004U45302024-08-15
00380740155872ARCHITECT04T342004T34202024-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10673486013580Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
10673486013726Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
10673486013894Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
10673486013962Teco Diagnostics TC Matrix Clinical Chemistry AnalyzerTECO DIAGNOSTICSCKA2025-05-28
07613336130513Alanine Aminotransferase acc. to IFCC IIRoche Diagnostics GmbHCKA2024-01-26
00850053916021IDG/SANZAYIDG/SANZAY CorporationCKA2024-01-03
10673486001082ALT (SGPT) LIQUID REAGENT (KINETIC METHOD)TECO DIAGNOSTICSCKA2023-07-17
10673486001099ALT (SGPT) KINETIC METHOD TC MATRIX-240/480TECO DIAGNOSTICSCKA2023-07-17
10673486001105ALT (SGPT) REAGENT SET (UV-KINETIC METHOD)TECO DIAGNOSTICSCKA2023-07-17
10673486001112ALT (SGPT) REAGENT SET (UV-KINETIC METHOD)TECO DIAGNOSTICSCKA2023-07-17
06971674862031BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862048BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862055BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862062BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862079BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862086BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862093BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862109BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862116BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862123BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862130BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862147BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862154BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862161BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862178BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862185BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862192BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
06971674862208BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CKA2023-07-13
00817302024647CAROLINA LIQUID CHEMISTRIES CORP.® ALKALINE AMINOTRANSFERASE REAGENT AU-240CAROLINA LIQUID CHEMISTRIES CORPORATIONCKA2022-10-18
00817302024111CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218CAROLINA LIQUID CHEMISTRIES CORPORATIONCKA2022-08-19