FDA.reportPublic FDA data

Alinity

Primary DI
00380740135294
Brand
Alinity
Company
Abbott GmbH
Model
07P7330
Catalog number
07P7330
Device description
Alinity c Gamma-Glutamyl Transferase Reagent Kit
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
JPZCOLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPZColorimetric Method, Gamma-Glutamyl TranspeptidaseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740135294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740135294003807401352943807401352940380740135294

GMDN Terms#

Term, Definition table
TermDefinition
Gamma-glutamyltransferase (GGT) 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 gamma glutamyltransferase (GGT) 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
06971674861676BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861683BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861713BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861720BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861737BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861744BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861768BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861799BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861805BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861812BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861829BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861836BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861843BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-21
06971674861690BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-20
06971674861706BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-20
06971674861751BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-20
06971674861775BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-20
06971674861782BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JPZ2023-07-20
05055273203462GAMMA-GLUTAMYLTRANSERASE (GGT)RANDOX LABORATORIES LIMITEDJPZ2022-09-22
05055273208801GAMMA-GLUTAMYLTRANSERASE (GGT)RANDOX LABORATORIES LIMITEDJPZ2022-09-22
05055273215502GAMMA-GLUTAMYLTRANSERASE (GGT)RANDOX LABORATORIES LIMITEDJPZ2022-09-22
00817302024159CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT BL209CAROLINA LIQUID CHEMISTRIES CORPORATIONJPZ2022-08-19
00817302024395CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT DT209CAROLINA LIQUID CHEMISTRIES CORPORATIONJPZ2022-08-19
00817302024531CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT ST209CAROLINA LIQUID CHEMISTRIES CORPORATIONJPZ2022-08-19
00380740155308AlinityABBOTT IRELANDJPZ2022-06-14
00380740155315AlinityABBOTT IRELANDJPZ2022-06-14
00380740155896ARCHITECTABBOTT IRELANDJPZ2022-06-14
00380740155902ARCHITECTABBOTT IRELANDJPZ2022-06-14
00380740161712ARCHITECTAbbott GmbHJPZ2020-02-29
00380740161729ARCHITECTAbbott GmbHJPZ2020-02-29