Stratus® CS Acute Care™ cTNI TestPak

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics

Identity

Trade Name: Stratus® CS Acute Care™ cTNI TestPak FDA UDI
Generic Name: Troponin I IVD, kit, fluorescent immunoassay FDA UDI
Device Name: The Stratus® CS Acute Care™ Troponin I method (cTNI) is an in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. FDA UDI
Model / Reference: 10445071 FDA UDI
Description: The Stratus® CS Acute Care™ Troponin I method (cTNI) is an in vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. FDA UDI

Identifiers

Catalog Number: CCTNI FDA UDI
Primary DI / UDI-DI: 00842768004520 FDA UDI
510(k) Number: K051650 FDA UDI
FDA Product Code: MMI FDA UDI
JIT FDA UDI
JHX FDA UDI
DDR FDA UDI
GMDN Term: Troponin I IVD, kit, fluorescent immunoassay FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 862.1215 FDA UDI
862.1150 FDA UDI
866.5680 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Troponin I IVD, kit, fluorescent immunoassay

Stratus® CS Acute Care™ cTNI TestPak by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Troponin I IVD, kit, fluorescent immunoassay.

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Triage — Quidel Cardiovascular Inc. · Class II
Fluoro-CheckTM cTnI — Nano-Ditech Corporation · Class II
Stratus® CS Acute Care™ cTNI CalPak — Siemens Healthcare Diagnostics · Class II
Stratus® CS Acute Care™ cTNI DilPak — Siemens Healthcare Diagnostics · Class II

Cleared under the same submission

K051650 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Siemens Healthcare Diagnostics

Sources (1)

FDA UDI 7c1a06be-cccd-45e3-a42e-295df7773a48 37 fields · synced May 30, 2026