FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740012984
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
7D74-21
Catalog number
07D7421
Device description
Triglyceride
Published
2016-06-06
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740012984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740012984003807400129843807400129840380740012984

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 Temperature029 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)422-2268xx@xx.xx
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
079226220
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
00380740136963Alinity07P810407P81042023-11-16
00380740136994Alinity07P830107P83012023-11-16
00380740137007Alinity07P800407P80042023-11-16
00380740137021Alinity07P790407P79042023-11-16
00380740153694Alinity01R130201R13022023-10-14
00380740153762Alinity04R461204R46122023-10-14
00380740156305ARCHITECT06K460406K46042020-03-03
00380740156381ARCHITECT06K542206K54222020-03-03
00380740156398ARCHITECT06K552306K55232020-03-03
00380740030056ARCHITECT6K46-0206K46022018-07-31
00380740044831ARCHITECT6K54-2106K54212018-07-31
00380740045593ARCHITECT6K55-2206K55222018-07-31
00380740202798Alinity04W560704W56072025-07-21
00380740203108Alinity04W561504W56152025-07-21
00380740203115Alinity04W562504W56252025-07-21
00380740203139Alinity04W566104W56612025-07-21
00380740192402CELL-DYN09H600309H60032020-12-18
00380740020132CELL-DYN09H46-0209H46022016-06-06
00380740020149CELL-DYN09H47-0209H47022016-06-06
00380740020156CELL-DYN09H48-0209H48022016-06-06

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