FDA.reportPublic FDA data

Poly Rb A-Hu Prealbumin

Primary DI
05700572000211
Brand
Poly Rb A-Hu Prealbumin
Company
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
Model
A0002
Device description
Polyclonal Rabbit Anti-Human Prealbumin
Published
2020-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
05700572000211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05700572000211057005720002115700572000211

GMDN Terms#

Term, Definition table
TermDefinition
Prealbumin (transthyretin) IVD, antibodyOne or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of prealbumin (transthyretin) in a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4544859500dako.dkregulatory@agilent.com

Regulatory Flags#

DUNS number
894671143
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05700572033028DakoGA6332026-05-15
05700572033127DakoGA6142026-05-16
05700572033363DakoGA6282026-05-15
05700572034230DakoGA6272026-05-16
05700572005322Mono Mo A-Hu Serotonin Cl 5HT-H209M07582020-09-17
05700574035631Alissa InterpretK5849AA2022-07-11
05700572027799Poly Rb A-Hu Alpha-1-FetoproteinA00082020-09-17
05700572005841Mono Mo A-Hu CD35 Cl Ber-MAC-DRCM08462020-09-17
05700572004912Mono Mo A-Vimentin Cl V9M07252020-09-17
05700572027942Mono Mo A-Vimentin Cl V9M07252020-09-17
05700572516170Mono Mo A-Epstein-Barr Virus, LMP Cls CS. 1-4M08972020-09-17
05700571112182DakoGC1182025-09-02
05700575013812Dako Omnis DI Water Filling AccessoriesGC1212025-06-25
05700575014017Dako Omnis Clean Liquid System HardwareGC1222025-06-25
05700575014031Dako Omnis Waste Tank (NHz)GC1262025-06-25
05700575014048Dako Omnis Waste Tank (Hz)GC1272025-06-25
05700575014413Dako Omnis Waste Accessories (Direct)GC1232025-06-25
05700575014420Dako Omnis Waste Accessories (Indirect)GC1242025-06-25
05700572007340Poly Rb A-Hu IgG/HRPP02142016-09-16
05700575000416Dako Omnis 165 DuoGI1002025-07-01

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
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
00380740009861ARCHITECTABBOTT 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