Identity
- Trade Name
- ADVIA Centaur® TnI-Ultra MCM FDA UDI
- Generic Name
- Troponin I IVD, control FDA UDI
- Device Name
- Troponin I Ultra Master Curve Material Set - CENTAUR - CONS FDA UDI
- Model / Reference
- 10317626 FDA UDI
- Description
- Troponin I Ultra Master Curve Material Set - CENTAUR - CONS FDA UDI
Identifiers
- Catalog Number
- 2738323 FDA UDI
- Primary DI / UDI-DI
- 00630414515892 FDA UDI
- 510(k) Number
- K140267 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
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: Troponin I IVD, control
ADVIA Centaur® TnI-Ultra MCM by Siemens Healthcare Diagnostics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Troponin I IVD, control.
- i-STAT hs-TnI Control Level 2 — Abbott Point of Care Inc. · Class I
- i-STAT — Abbott Point of Care Inc. · Class I
- i-STAT — Abbott Point of Care Inc. · Class I
- i-STAT — Abbott Point of Care Inc. · Class I
- i-STAT hs-TnI Control Level 1 — Abbott Point of Care Inc. · Class I
- IMMULITE® Systems TPI Calibration Verification Material Troponin I — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- ARCHITECT — ABBOTT IRELAND · Class I
- ARCHITECT — Abbott Laboratories, Inc. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 5818a371-fd7f-440b-add9-701fe0a5a050 37 fields · synced May 30, 2026