FDA.reportPublic FDA data

Atellica CH Prealbumin (PALB)

Primary DI
00630414313412
Brand
Atellica CH Prealbumin (PALB)
Company
Siemens Healthcare Diagnostics Inc.
Model
11537217
Catalog number
11537217
Device description
Atellica CH Prealbumin (PALB)
Published
2024-02-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00630414614939PrimaryGS10
00630414313412Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00630414614939006304146149396304146149390630414614939
00630414313412006304143134126304143134120630414313412

GMDN Terms#

Term, Definition table
TermDefinition
Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the quantitative measurement of prealbumin (transthyretin) in a clinical specimen, using a nephelometry/turbidimetry method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
064608573
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630414124797ADVIA Centaur® Calibrator D10311569103115692014-09-24
00630414124933ADVIA Centaur® Systems, ACS:180® Systems Calibrator D10311576103115762014-09-24
00630414126319ADVIA Centaur® Systems, ACS 180® Systems AFP MCM10311625103116252014-09-24
00630414177335ADVIA Centaur® AFP10309980103099802014-09-24
00630414238791Atellica IM AFP11202257112022572018-11-14
00630414238807Atellica IM AFP11202258112022582018-11-14
00630414597720Atellica IM AFP MCM10995443109954432018-11-14
00630414279176ADVIA Chemistry UCFP11319151113191512020-03-06
00630414209845ADVIA® Chemistry MG Magnesium Reagents10341119103411192020-09-24
00630414474748ADVIA® Chemistry TIBC Total Iron Binding Capacity Reagents10309071103090712020-09-24
00630414508399ADVIA® Chemistry IP Inorganic Phosphorus Reagents10309503103095032020-09-24
00630414508429ADVIA® Chemistry MG Magnesium Reagents10309506103095062020-09-24
00630414561073ADVIA® Chemistry CHOL_2 Cholesterol_2 Reagent10376501103765012020-09-24
00630414561974ADVIA® Chemistry IRON_2 Iron 2 Reagents10377510103775102020-09-24
00630414279183ADVIA Chemistry UCFP Calibrator11319152113191522020-03-06
00842768013836Dimension Cardiac Troponin-I Flex reagent cartridge10444905104449052016-09-24
00842768013904Dimension Cardiac Troponin-I Flex reagent cartridge10444896104448962016-09-24
00630414008967ADVIA® Chemistry Enzyme 1 Calibrator10916057109160572016-09-24
00630414177328ADVIA Centaur® AFP10309979103099792014-09-24
00630414553153ADVIA® Chemistry (AST_c) AST(GOT) Reagents Concentrated10283343102833432016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414614939Atellica 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
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