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Stratus® CS STAT Fluorometric Analyzer Sample Cups
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Stratus® CS STAT Fluorometric Analyzer Sample Cups FDA UDI
- Generic Name
- General laboratory container, single-use FDA UDI
- Device Name
- Stratus® CS STAT Fluorometric Analyzer sample cups are used to introduce quality control (QC) material or previously centrifuged plasma for processing. FDA UDI
- Model / Reference
- 10445074 FDA UDI
- Description
- Stratus® CS STAT Fluorometric Analyzer sample cups are used to introduce quality control (QC) material or previously centrifuged plasma for processing. FDA UDI
Identifiers
- Catalog Number
- CCUPS FDA UDI
- Primary DI / UDI-DI
- 00842768004551 FDA UDI
- 510(k) Number
- K984067 FDA UDI
- FDA Product Code
- JHX FDA UDI
- GMDN Term
- General laboratory container, single-use 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: General laboratory container, single-use
Stratus® CS STAT Fluorometric Analyzer Sample Cups by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K984067 also covers:
- Stratus CS Acute Care CCRP CalPak — Siemens Healthcare Diagnostics
- Stratus® CS — Siemens Healthcare Diagnostics
- Stratus® CS Acute Care™ CCRP TestPak — 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 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI ac4597cf-050f-471a-b98d-9e16d9594b95 37 fields · synced May 30, 2026