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IMMULITE® Systems TPI Calibration Verification Material Troponin I
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- IMMULITE® Systems TPI Calibration Verification Material Troponin I FDA UDI
- Generic Name
- Troponin I IVD, control FDA UDI
- Device Name
- Troponin I CVM - IMMULITE - CONS FDA UDI
- Model / Reference
- 10373707 FDA UDI
- Description
- Troponin I CVM - IMMULITE - CONS FDA UDI
Identifiers
- Catalog Number
- LTICVM FDA UDI
- Primary DI / UDI-DI
- 00630414971391 FDA UDI
- 510(k) Number
- K143636 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Troponin I IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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, control
IMMULITE® Systems TPI Calibration Verification Material Troponin I by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID
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Also classified as Troponin I IVD, control.
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- i-STAT — Abbott Point of Care Inc. · Class I
- i-STAT hs-TnI Control Level 1 — Abbott Point of Care Inc. · Class I
- ADVIA Centaur® TnI-Ultra MCM — Siemens Healthcare Diagnostics · Class I
- ARCHITECT — ABBOTT IRELAND · Class I
Cleared under the same submission
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 f7f3e8f8-7af6-4a38-8d33-7a3172d46d00 37 fields · synced May 30, 2026