← Back to catalogue
Stratus® CS STAT Fluorometric Analyzer Waste Container
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Stratus® CS STAT Fluorometric Analyzer Waste Container FDA UDI
- Generic Name
- Contaminated waste container FDA UDI
- Device Name
- Stratus® CS STAT Fluorometric Analyzer Waste Container holds used rotors, tips, cups and paks and is an in vitro diagnostic product intended to be used on the Stratus® CS analyzer. FDA UDI
- Model / Reference
- 10445078 FDA UDI
- Description
- Stratus® CS STAT Fluorometric Analyzer Waste Container holds used rotors, tips, cups and paks and is an in vitro diagnostic product intended to be used on the Stratus® CS analyzer. FDA UDI
Identifiers
- Catalog Number
- CLINER FDA UDI
- Primary DI / UDI-DI
- 00842768004599 FDA UDI
- 510(k) Number
- K984067 FDA UDI
- FDA Product Code
- JHX FDA UDI
- GMDN Term
- Contaminated waste container 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Contaminated waste container
Stratus® CS STAT Fluorometric Analyzer Waste Container by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Contaminated waste container.
- HALYARD — GRI Medical & Electronic Technology Co., Ltd. · Class I
- Alleset — GRI Medical & Electronic Technology Co., Ltd. · Class I
- Unisurge — GRI Medical & Electronic Technology Co., Ltd. · Class I
- Alleset — GRI Medical & Electronic Technology Co., Ltd. · Class I
- Alleset — GRI Medical & Electronic Technology Co., Ltd. · Class I
- Essentials — HENRY SCHEIN, INC. · Class II
- Alleset — GRI Medical & Electronic Technology Co., Ltd. · Class I
- Alleset — GRI Medical & Electronic Technology Co., Ltd. · Class I
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 Sample Cups — 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 a3dd0c49-009c-476f-b646-9049c0e28edf 36 fields · synced Jun 8, 2026