FDA.reportPublic FDA data

Alinity

Primary DI
00380740136062
Brand
Alinity
Company
Abbott GmbH
Model
07P9820
Catalog number
07P9820
Device description
Alinity c Alanine Aminotransferase Reagent Kit 3600 Tests
Published
2018-07-11
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
00380740136062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740136062003807401360623807401360620380740136062

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 Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature030 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
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
315786293
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
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189815Alinity09P263509P26352026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01

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