Identity
- Trade Name
- IMMULITE® 2000 Systems TPI Troponin I FDA UDI
- Generic Name
- Troponin I IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 10642239 FDA UDI
Identifiers
- Catalog Number
- L2KTI2(D) FDA UDI
- Primary DI / UDI-DI
- 00630414986098 FDA UDI
- 510(k) Number
- K983972 FDA UDI
- FDA Product Code
- MMI FDA UDI
- GMDN Term
- Troponin I IVD, kit, chemiluminescent immunoassay 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: Troponin I IVD, kit, chemiluminescent immunoassay
IMMULITE® 2000 Systems TPI Troponin I by Siemens Healthcare Diagnostics Products Ltd — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (2)
- FDA UDI c513e45d-5fa7-42b6-ab37-bb6755a50f0e 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026