FDA.reportPublic FDA data

Elecsys beta-Amyloid (1-42) CSF II

Primary DI
07613336166321
Brand
Elecsys beta-Amyloid (1-42) CSF II
Company
Roche Diagnostics GmbH
Model
08821941190
Catalog number
08821941190
Published
2022-12-17
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
K221842000
K231348000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221842000Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSFRoche Diagnostics2022-12-07QSE
K231348000Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSFRoche Diagnostics2023-06-05QSE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336166321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336166321076133361663217613336166321

GMDN Terms#

Term, Definition table
TermDefinition
Amyloid B component IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of amyloid B component, also known as amyloid beta or Aß, in a clinical specimen, using a chemiluminescent immunoassay 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
Primary DIBrandModelCatalogPublished
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336221761Elecsys Total -Tau CSFRoche Diagnostics GmbHQSE2023-08-23
07613336167649Elecsys Total-Tau CSFRoche Diagnostics GmbHQSE2023-08-11
07613336167663Elecsys Phospho-Tau (181P) CSFRoche Diagnostics GmbHQSE2022-12-17
07613336208366Elecsys Phospho-Tau (181P) CSFRoche Diagnostics GmbHQSE2022-12-17
07613336208359Elecsys Beta-Amyloid (1-42) CSF IIRoche Diagnostics GmbHQSE2022-12-17