ADVIA Centaur High-Sensitivity Troponin I (TNIH)

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

ADVIA Centaur High-Sensitivity Troponin I (TNIH) EUDAMED

ADVIA Centaur TNIH 500T Kit GUDID

Generic Name

Troponin I IVD, kit, chemiluminescent immunoassay

Device Name

IVDR_67_TTN_DUB-C_C_KIT_TnIH

Model / Ref / Catalog

10994775, IVDR_67_TTN_DUB-C_C_KIT_TnIH

Primary DI / UDI-DI

00630414602929

Basic UDI-DI

0405686900809VV

510(k) Number

K171274 ↗

FDA Product Code

MMI

EMDN Code

W01021306 Troponin i/t

GMDN Term

Troponin I IVD, kit, chemiluminescent immunoassay

Device Class

Class C EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 862.1215

EU market of registration

Germany

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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See all devices from Siemens Healthcare Diagnostics →

• What clinical applications is the ADVIA Centaur High-Sensitivity Troponin I (TNIH) primarily used for?

  The ADVIA Centaur High-Sensitivity Troponin I (TNIH) is designed to quantitatively measure low concentrations of cardiac troponin I in human serum or plasma. Its high sensitivity makes it particularly useful in clinical chemistry for evaluating acute myocardial infarction, helping clinicians detect early signs of heart attacks with greater precision.

• Is the ADVIA Centaur High-Sensitivity Troponin I (TNIH) a single-use or reusable device, and how should it be stored?

  The ADVIA Centaur High-Sensitivity Troponin I (TNIH) is supplied as a single-use reagent. Storage requirements are standard and align with the manufacturer’s instructions—no special conditions are specified beyond typical laboratory storage guidelines for immunoassay reagents.

• Which platforms or systems is this device compatible with, and how does that affect its use?

  The ADVIA Centaur High-Sensitivity Troponin I (TNIH) is specifically intended for use on the ADVIA Centaur XP and ADVIA Centaur XPT systems. Compatibility with these platforms ensures seamless integration into clinical workflows designed for these analyzers, enabling accurate troponin I measurement as part of routine cardiac diagnostics.

• What regulatory pathways does the ADVIA Centaur High-Sensitivity Troponin I (TNIH) follow, and what does that mean for its use?

  The device is authorized under FDA 510(k) clearance and IVDR (In Vitro Diagnostic Regulation) compliance, confirming its adherence to stringent U.S. and European regulatory standards. This means it has undergone validation for safety, performance, and clinical utility, ensuring reliable results for diagnosing cardiac conditions like acute myocardial infarction.