FDA.reportPublic FDA data

ARCHITECT

Primary DI
00380740009861
Brand
ARCHITECT
Company
ABBOTT LABORATORIES
Model
6E57-02
Catalog number
06E5702
Device description
Prealbumin Calibrator
Published
2018-07-31
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
JZJPREALBUMIN, ANTIGEN, ANTISERUM, CONTROL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZJPrealbumin, Antigen, Antiserum, ControlImmunology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740009861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740009861003807400098613807400098610380740009861

GMDN Terms#

Term, Definition table
TermDefinition
Prealbumin (transthyretin) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of prealbumin (transthyretin) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity0 Percent (%) Relative Humidity
Handling Environment Temperature029 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
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
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
00380740120771CELL-DYN09H610109H61012016-09-09
00380740120788CELL-DYN09H62-0109H62012016-09-09
00380740202668Alinity06P010706P01072025-10-03
00380740202828Alinity06P011506P01152025-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414614939Atellica CH Prealbumin (PALB)Siemens Healthcare Diagnostics Inc.JZJ2024-02-02
00630414313412Atellica CH Prealbumin (PALB)Siemens Healthcare Diagnostics Inc.JZJ2024-02-02
06971674867203BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZJ2023-07-24
06971674867210BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZJ2023-07-24
06971674867258BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZJ2023-07-24
06971674867265BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZJ2023-07-24
06971674867968BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZJ2023-07-24
06971674867227BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZJ2023-07-22
06971674867234BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZJ2023-07-22
06971674867241BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JZJ2023-07-22
05055273204759PREALBUMIN (PreALB)RANDOX LABORATORIES LIMITEDJZJ2022-10-05
00380740169947AlinityABBOTT IRELANDJZJ2021-05-19
04015630913787Prealbumin - Application for C.f.a.s. PACRoche Diagnostics GmbHJZJ2021-01-18
04015630928804PrealbuminRoche Diagnostics GmbHJZJ2021-01-18
00630414517704ADVIA® Chemistry PREALB Prealbumin ReagentsSiemens Healthcare Diagnostics Inc.JZJ2020-09-24
00630414596259Atellica CH PreAlbSiemens Healthcare Diagnostics Inc.JZJ2020-09-24
00842768011399N Antiserum to Human PrealbuminSiemens Healthcare Diagnostics Products GmbHJZJ2020-09-24
00842768006210DImension Vista® Prealbumin Flex® reagent cartridgeSiemens Healthcare Diagnostics Products GmbHJZJ2020-09-24
05700572000211Poly Rb A-Hu PrealbuminAGILENT TECHNOLOGIES SINGAPORE PTE LTDJZJ2020-09-17
03610230007396Yumizen C1200 PrealbuminHORIBA ABX SASJZJ2020-08-31
10758750006908VITROSORTHO-CLINICAL DIAGNOSTICS, INC.JZJ2020-04-18
07613336147894PrealbuminRoche Diagnostics GmbHJZJ2020-03-05
00380740174897ARCHITECTAbbott GmbHJZJ2020-02-29
00380740150709AlinityAbbott GmbHJZJ2018-10-05
00380740000219ARCHITECTABBOTT LABORATORIESJZJ2018-07-31
B1761540Antiserum to Human PrealbuminKENT LABORATORIES INCJZJ2016-09-24
B1761545Prealbumin RID plate kitKENT LABORATORIES INCJZJ2016-09-24
05051700010771Human Prealbumin BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDJZJ2016-09-24
05051700016100Human Prealbumin Kit for use on SPAPLUSTHE BINDING SITE GROUP LIMITEDJZJ2016-09-24
05051700018135Optilite Prealbumin KitTHE BINDING SITE GROUP LIMITEDJZJ2016-09-24