ADVIA Centaur® FT3
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ADVIA Centaur® FT3 EUDAMEDFDA UDI
- Generic Name
- Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_B_REAG_FT3 EUDAMEDFree T3 - CENTAUR - RGT - 50 tests FDA UDI
- Model / Reference
- 10310317 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_B_REAG_FT3 EUDAMED
- Description
- Free T3 - CENTAUR - RGT - 50 tests FDA UDI
Identifiers
- Catalog Number
- 119780 FDA UDI
- Primary DI / UDI-DI
- 00630414207520 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901713VN EUDAMED
- 510(k) Number
- K991692 FDA UDI
- FDA Product Code
- CDP FDA UDI
- EMDN Code
- W01020401 FREE TRIIODOTHYRONINE EUDAMED
- GMDN Term
- Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1710 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® FT3 by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K991692 also covers:
- ADVIA Centaur® FT3 — Siemens Healthcare Diagnostics
- ADVIA Centaur® FT3 — Siemens Healthcare Diagnostics
- ADVIA Centaur® FT3 MCM — Siemens Healthcare Diagnostics
- Atellica IM FT3 — Siemens Healthcare Diagnostics
- Atellica IM FT3 — Siemens Healthcare Diagnostics
- Atellica IM FT3 — Siemens Healthcare Diagnostics
- Atellica IM FT3 MCM — Siemens Healthcare Diagnostics
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
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
Sources (2)
- FDA UDI 17e0465a-d17a-4b07-97f2-97bcaa585df7 37 fields · synced Jun 11, 2026
- EUDAMED fd3187c4-b0b3-487f-a5a0-dd8216bdb5b3 61 fields · synced Jun 11, 2026