Identity
- Trade Name
- Stratus® CS STAT Fluorometric Analyzer Cannula FDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, laboratory, semi-automated FDA UDI
- Device Name
- For the cannulation of B-D Vacutainer® 4 or 5 mL lithium heparin collection tubes, with HEMOGARD® closure, to be used on the Stratus® CS STAT Fluorometric Analyzer. FDA UDI
- Model / Reference
- 10445063 FDA UDI
- Description
- For the cannulation of B-D Vacutainer® 4 or 5 mL lithium heparin collection tubes, with HEMOGARD® closure, to be used on the Stratus® CS STAT Fluorometric Analyzer. FDA UDI
Identifiers
- Catalog Number
- CCANBD FDA UDI
- Primary DI / UDI-DI
- 00842768004438 FDA UDI
- 510(k) Number
- K984067 FDA UDI
- FDA Product Code
- JHX FDA UDI
- GMDN Term
- Fluorescent immunoassay analyser IVD, laboratory, semi-automated 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: Fluorescent immunoassay analyser IVD, laboratory, semi-automated
Stratus® CS STAT Fluorometric Analyzer Cannula by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluorescent immunoassay analyser IVD, laboratory, semi-automated.
- CELLTRACKS ANALYZER II — Menarini Silicon Biosystems Inc. · Class II
- ALFIS-3 — Boditech Med, Inc.
- CELLTRACKS ANALYZER II — Menarini Silicon Biosystems Inc. · Class II
- CELLTRACKS ANALYZER II — Menarini Silicon Biosystems Inc. · Class II
- CELLTRACKS ANALYZER II — Menarini Silicon Biosystems Inc. · Class II
- Stratus® CS STAT Fluorometric Analyzer Cannula — Siemens Healthcare Diagnostics · Class II
- Stratus® CS — 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 Acute Care™ CCRP TestPak — 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 37550c39-7394-43ba-8cdf-5b0c2222ed8b 37 fields · synced Jun 1, 2026