Identity
- Trade Name
- Stratus® CS Acute Care™ cTNI DilPak FDA UDI
- Generic Name
- Troponin I IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- The Stratus® CS Acute Care™ Cardiac Troponin I Dilution Pak (cTNI DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ cTNI TestPak on the Stratus® CS analyzer for the measurement of samples with elevated levels of cardiac Troponin I. FDA UDI
- Model / Reference
- 10445073 FDA UDI
- Description
- The Stratus® CS Acute Care™ Cardiac Troponin I Dilution Pak (cTNI DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care™ cTNI TestPak on the Stratus® CS analyzer for the measurement of samples with elevated levels of cardiac Troponin I. FDA UDI
Identifiers
- Catalog Number
- CCTNI-D FDA UDI
- Primary DI / UDI-DI
- 00842768004544 FDA UDI
- 510(k) Number
- K051650 FDA UDI
- FDA Product Code
- JIT FDA UDIMMI FDA UDIJHX FDA UDIDDR FDA UDI
- GMDN Term
- Troponin I IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI862.1215 FDA UDI866.5680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Troponin I IVD, kit, fluorescent immunoassay
Stratus® CS Acute Care™ cTNI DilPak 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.
- Triage — Quidel Cardiovascular Inc. · Class II
- Triage — Quidel Cardiovascular Inc. · Class II
- Fluoro-CheckTM cTnI — Nano-Ditech Corporation · Class II
- Stratus® CS Acute Care™ cTNI TestPak — Siemens Healthcare Diagnostics · Class II
- Stratus® CS Acute Care™ cTNI CalPak — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K051650 also covers:
- Stratus® CS Acute Care™ CKMB CalPak — Siemens Healthcare Diagnostics
- Stratus® CS Acute Care™ CKMB DilPak — Siemens Healthcare Diagnostics
- Stratus® CS Acute Care™ CKMB TestPak — Siemens Healthcare Diagnostics
- Stratus® CS Acute Care™ MYO DilPak — Siemens Healthcare Diagnostics
- Stratus® CS Acute Care™ MYO TestPak — Siemens Healthcare Diagnostics
- Stratus® CS Acute Care™ Myoglobin CalPak — Siemens Healthcare Diagnostics
- Stratus® CS Acute Care™ cTNI CalPak — Siemens Healthcare Diagnostics
- Stratus® CS Acute Care™ cTNI TestPak — Siemens Healthcare Diagnostics
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 c7e8282c-8c8b-4f12-9a8d-d52921ff3bc2 37 fields · synced May 30, 2026