FDA.reportPublic FDA data

Elecsys Phospho-Tau (181P) Plasma

Primary DI
07613336216941
Brand
Elecsys Phospho-Tau (181P) Plasma
Company
Roche Diagnostics GmbH
Model
09697870190
Catalog number
09697870190
Published
2025-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SETImmunoassay blood test for amyloid pathology assessment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SETImmunoassay Blood Test For Amyloid Pathology AssessmentImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252163000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252163000Elecsys Phospho-Tau (181P) PlasmaRoche Diagnostics2025-10-08SET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613336216941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613336216941076133362169417613336216941

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 microtubule-associated tau protein [total tau (t-tau) or phosphorylated tau (p-tau)] in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid the diagnosis of neurodegenerative disorders such as Alzheimer's disease.

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
07613336217702Elecsys T309744975190097449751902026-09-04
07613336246672Elecsys Anti-HBc II09745009160097450091602026-09-04
07613336172827Elecsys DHEA-S II09043551190090435511902026-08-07
07613336172834Elecsys DHEA-S II09043560190090435601902026-08-07
07613336172841CalSet DHEA-S II09043586190090435861902026-08-07
07613336217696Elecsys Tg II09744967190097449671902026-08-07
07613336217764Elecsys Anti-Tg09745602190097456021902026-08-07
07613336223321Kidney KFRE Algorithm09891986001098919860012025-03-31
07613336234457PreciControl Syphilis09465022190094650221902026-05-15
04015630913893AMYP Amylase EPS Pancreatic20766623322207666233222016-09-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04987270235720Lumipulse G pTau 217 Plasma Immunoreaction CartridgesFUJIREBIO INC.SET2026-06-23
04987270235737Lumipulse G pTau 217 Plasma CalibratorsFUJIREBIO INC.SET2026-06-23
05414470815500Lumipulse G pTau 217 Plasma Immunoreaction CartridgesFujirebio EuropeSET2025-06-16
05414470815579Lumipulse G pTau 217 Plasma CalibratorsFujirebio EuropeSET2025-06-16
05414470815586Lumipulse pTau 217 Plasma ControlsFujirebio EuropeSET2025-06-16
05414470815593Lumipulse B-Amyloid Plasma ControlsFujirebio EuropeSET2025-06-16
04987270235447Lumipulse G B-Amyloid 1-42-N PlasmaFUJIREBIO INC.SET2025-01-06
04987270235454Lumipulse G B-Amyloid 1-42-N Plasma CalibratorFUJIREBIO INC.SET2025-01-06
00869164000086Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Fujirebio Diagnostics, Inc.SET2024-11-04