FDA.reportPublic FDA data

Prealbumin

Primary DI
04015630928804
Brand
Prealbumin
Company
Roche Diagnostics GmbH
Model
5950902190
Catalog number
5950902190
Published
2021-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
04015630928804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630928804040156309288044015630928804

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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04015630910991alpha-Amylase liquid acc. to IFCC11876473316118764733162016-09-20
04015630911004Pancreatic alpha-amylase liquid11876562316118765623162016-09-20
04015630926848alpha-Amylase EPS Pancreatic540177119054017711902016-09-20
07613336121016a-Amylase EPS Pancreatic08056820190080568201902020-03-05
07613336171509Elecsys Calcitonin09005676190090056761902026-06-01
07613336171516CalSet Calcitonin09005684190090056841902026-06-01
07613336188064Elecsys Calcitonin09005668160090056681602026-06-01
07613336217641Elecsys Anti-TSHR09744819190097448191902026-06-01
07613336218341Elecsys CA 19-909755608190097556081902026-06-01
07613336218389Elecsys Estradiol III09755659190097556591902026-06-01
07613336235546PreciControl HIV Gen II09465006160094650061602026-05-22
07613336231432Tina-quant Antistreptolysin-O II09537368190095373681902026-05-08
07613336231449Tina-quant Antistreptolysin-O II09537341190095373411902026-05-08
07613336154342Elecsys Anti-HBc IgM11820567160118205671602017-09-29
07613336217832Elecsys Testosterone II09745963190097459631902026-04-21
07613336153932Elecsys Anti-HBc IgM07026811160070268111602018-03-19
00875197004748cobas® HBV/HCV/HIV-1 Control Kit1.0069988871902015-12-04
07613336203606Elecsys Anti-HBc II09014918160090149181602022-04-11

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
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