Identity
- Trade Name
- IMMULITE® 2000 XPi Immunoassay System FDA UDI
- Generic Name
- Chemiluminescent immunoassay analyser IVD FDA UDI
- Device Name
- IMMULITE® 2000 XPi Instrument FDA UDI
- Model / Reference
- 10373214 FDA UDI
- Description
- IMMULITE® 2000 XPi Instrument FDA UDI
Identifiers
- Catalog Number
- 030002-33 FDA UDI
- Primary DI / UDI-DI
- 00630414945422 FDA UDI
- 510(k) Number
- K970227 FDA UDI
- FDA Product Code
- JJE FDA UDI
- GMDN Term
- Chemiluminescent immunoassay analyser IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2160 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Chemiluminescent immunoassay analyser IVD
IMMULITE® 2000 XPi Immunoassay System by Siemens Medical Solutions Diagnostics Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chemiluminescent immunoassay analyser IVD.
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- Atellica IM 1300 Analyzer — Siemens Healthcare Diagnostics · Class I
- ARCHITECT — Abbott Laboratories, Inc. · Class I
- Atellica IM 1300 Analyzer — Siemens Healthcare Diagnostics · Class I
- Alinity — Abbott Laboratories, Inc. · N
Cleared under the same submission
K970227 also covers:
- IMMULITE® 2000 Systems PHE Phenobarbital — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems SUBS — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems TSH Third Generation TSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems TSH Third Generation TSH — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
- IMMULITE® 2000 Systems Allergen Tube Caps — Siemens Medical Solutions Diagnostics Limited
- IMMULITE® 2000 Systems Allergen Tubes — Siemens Medical Solutions Diagnostics Limited
- IMMULITE® 2000 XPi Sample Nesting Cups — Siemens Medical Solutions Diagnostics Limited
- IMMULITE® 2000 Xpi Sample Nesting Cups — Siemens Medical Solutions Diagnostics Limited
- VersaCell® X3 — Siemens Medical Solutions Diagnostics Limited
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 Medical Solutions Diagnostics Limited
Sources (1)
- FDA UDI 26e5c542-a106-4f20-82ec-019dbd8612ab 36 fields · synced May 30, 2026