Identity
- Trade Name
- Stratus® CS Acute Care™ CCRP TestPak FDA UDI
- Generic Name
- C-reactive protein (CRP) IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP method (hsCRP) is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma and is intended to be used on the Stratus® CS analyzer. FDA UDI
- Model / Reference
- 10445066 FDA UDI
- Description
- The Stratus® CS Acute Care™ CardioPhase® high sensitivity CRP method (hsCRP) is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in lithium and sodium heparin plasma and is intended to be used on the Stratus® CS analyzer. FDA UDI
Identifiers
- Catalog Number
- CCCRP FDA UDI
- Primary DI / UDI-DI
- 00842768004469 FDA UDI
- 510(k) Number
- K984067 FDA UDI
- FDA Product Code
- JHX FDA UDI
- GMDN Term
- C-reactive protein (CRP) IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1215 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: C-reactive protein (CRP) IVD, kit, fluorescent immunoassay
Stratus® CS Acute Care™ CCRP TestPak by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as C-reactive protein (CRP) IVD, kit, fluorescent immunoassay.
- Fluoro-CheckTM CRP Test — Nano-Ditech Corporation · Class II
- C-Reactive Protein HS ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- ichroma Reader — Boditech Med, Inc. · Class II
- C-Reactive Protein HS ELISA — DRG International, Inc. · Class II
- ichroma™ CRP — Boditech Med, Inc. · Class II
- Stratus CS Acute Care CCRP CalPak — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K984067 also covers:
- Stratus CS Acute Care CCRP CalPak — Siemens Healthcare Diagnostics
- Stratus® CS — Siemens Healthcare Diagnostics
- Stratus® CS STAT Fluorometric Analyzer Cannula — Siemens Healthcare Diagnostics
- Stratus® CS STAT Fluorometric Analyzer Cannula — Siemens Healthcare Diagnostics
- Stratus® CS STAT Fluorometric Analyzer Pipette Tips — Siemens Healthcare Diagnostics
- Stratus® CS STAT Fluorometric Analyzer Rotors — Siemens Healthcare Diagnostics
- Stratus® CS STAT Fluorometric Analyzer Sample Cups — Siemens Healthcare Diagnostics
- Stratus® CS STAT Fluorometric Analyzer Waste Container — 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 a5c9df95-0480-4ef4-ad23-7ba9b0862f1a 37 fields · synced Jun 1, 2026