Identity
- Trade Name
- IMMULITE 2000/XPi Probe Cleaning Kit FDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- For use in daily maintenance of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers FDA UDI
- Model / Reference
- 10385229 FDA UDI
- Description
- For use in daily maintenance of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers FDA UDI
Identifiers
- Catalog Number
- L2KPM FDA UDI
- Primary DI / UDI-DI
- 00842768028434 FDA UDI
- 510(k) Number
- K905215 FDA UDI
- FDA Product Code
- JJQ FDA UDI
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Wash/cleaning solution IVD, automated/semi-automated system
IMMULITE 2000/XPi Probe Cleaning Kit by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K905215 also covers:
- IMMULITE 2000/XPi Probe Wash Module — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® Probe Cleaning Kit — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® Probe Wash Module — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE®/IMMULITE® 1000 Systems SUBS — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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 I | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 82d9703b-bf04-4452-b95c-72e6683b72b5 37 fields · synced May 29, 2026