FDA.reportPublic FDA data

Alinity

Primary DI
00380740135218
Brand
Alinity
Company
Abbott GmbH
Model
07P7720
Catalog number
07P7720
Device description
Alinity c Triglyceride 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
CDTLIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDTLipase Hydrolysis/Glycerol Kinase Enzyme, TriglyceridesClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K953971000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K953971000TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISATION TECHNOLOGYTrace America, Inc.1996-04-05CDT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740135218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740135218003807401352183807401352180380740135218

GMDN Terms#

Term, Definition table
TermDefinition
Triglyceride 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 triglycerides 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
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
00850053916151IDG/SanzayIDG/SANZAY CorporationCDT2024-01-12
10673486002256Teco Diagnostics Triglyceride - GPO Liquid Reagent SetTECO DIAGNOSTICSCDT2023-11-30
10673486002270Teco Diagnostics Triglyceride - GPO Liquid Reagent SetTECO DIAGNOSTICSCDT2023-11-28
10673486002287Teco Diagnostics Triglyceride - GPO Liquid Reagent SetTECO DIAGNOSTICSCDT2023-11-28
10673486002294Teco Diagnostics Triglyceride Reagent Kit TC-MatrixTECO DIAGNOSTICSCDT2023-11-28
10673486002225Teco Diagnostics Triglyceride -GPO Reagent SetTECO DIAGNOSTICSCDT2023-11-14
10673486002232Teco Diagnostics Triglyceride -GPO Reagent SetTECO DIAGNOSTICSCDT2023-11-14
06971674860228BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860266BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860280BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860303BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860310BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860327BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860334BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860341BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860358BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860365BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860372BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860389BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674868088BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-11
06971674860204BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860211BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860235BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860242BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860259BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860273BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
06971674860297BIOBASEBiobase Biodustry(Shandong)Co., Ltd.CDT2023-07-08
05055273209549TRIGLYCERIDES (TRIGS)RANDOX LABORATORIES LIMITEDCDT2022-10-05
00817302024180CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDE REAGENT KIT BL213CAROLINA LIQUID CHEMISTRIES CORPORATIONCDT2022-08-19
00817302024265CAROLINA LIQUID CHEMISTRIES CORP.® TRIGLYCERIDES REAGENT KIT CC213CAROLINA LIQUID CHEMISTRIES CORPORATIONCDT2022-08-19