FDA.reportPublic FDA data

Elecsys Total-Tau CSF

Primary DI
07613336167649
Brand
Elecsys Total-Tau CSF
Company
Roche Diagnostics GmbH
Model
08846685190
Catalog number
08846685190
Published
2023-08-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QSEAlzheimer’s disease pathology assessment test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSEAlzheimer’S Disease Pathology Assessment TestImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231348000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231348000Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSFRoche Diagnostics2023-06-05QSE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336167649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336167649076133361676497613336167649

GMDN Terms#

Term, Definition table
TermDefinition
Tau protein IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of tau protein, also known as beta-2 transferrin, in a clinical specimen using an enzyme immunoassay (EIA) method. It is used to aid the diagnosis of Alzheimer's disease.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
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07613336234457PreciControl Syphilis09465022190094650221902026-05-15
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
07613336203613Elecsys Anti-HBc II09014926160090149261602022-04-11
04015630938858Elecsys AntiHAV IgM11820591160118205911602016-09-20
04015630939855Elecsys Anti-HAV IgM07026773190070267731902017-09-07
07613336224397cobas ISE neo 1800 analytical unit09687416001096874160012026-04-03
20875197004766cobas&#x00AE MPX (96 tests)06998909190069989091902017-02-14
00875197004779cobas&#x00AE MPX (480 tests)06998917190069989171902017-02-14
07613336146996cobas® Microbial Inactivation Solution08185476001081854760012026-03-26
07613336200544cobas c 703 analytical unit09502971001095029710012026-03-20
07613336220191cobas pro SBL c 70309796754001097967540012026-03-20
07613336222331ISE Internal Standard Gen.2 conc.09137742190091377421902026-03-20
04015630926091Testosterone II CalSet II05202230190052022301902026-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336221761Elecsys Total -Tau CSFRoche Diagnostics GmbHQSE2023-08-23
07613336167663Elecsys Phospho-Tau (181P) CSFRoche Diagnostics GmbHQSE2022-12-17
07613336208366Elecsys Phospho-Tau (181P) CSFRoche Diagnostics GmbHQSE2022-12-17
07613336166321Elecsys beta-Amyloid (1-42) CSF IIRoche Diagnostics GmbHQSE2022-12-17
07613336208359Elecsys Beta-Amyloid (1-42) CSF IIRoche Diagnostics GmbHQSE2022-12-17