ADVIA Centaur® Tup
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ADVIA Centaur® Tup EUDAMEDFDA UDI
- Generic Name
- Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_B_KIT_TUp EUDAMEDT Uptake - CENTAUR - RGT - 50 tests FDA UDIT Uptake - CENTAUR - RGT - 250 tests FDA UDI
- Model / Reference
- 10309966 EUDAMEDFDA UDI10309967 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_B_KIT_TUp EUDAMED
- Description
- T Uptake - CENTAUR - RGT - 50 tests FDA UDIT Uptake - CENTAUR - RGT - 250 tests FDA UDI
Identifiers
- Catalog Number
- 110743 FDA UDI110744 FDA UDI
- Primary DI / UDI-DI
- 00630414177120 EUDAMEDFDA UDI00630414177137 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686901635VT EUDAMED
- Unit of Use DI
- 00630414003207 EUDAMED
- 510(k) Number
- K970539 FDA UDI
- FDA Product Code
- KHQ FDA UDI
- EMDN Code
- W01020406 T- UPTAKE EUDAMED
- GMDN Term
- Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1715 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: Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® Tup by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay.
- T3 Uptake AccuLite CLIA Test System - 192 Wells — MONOBIND, INC. · Class II
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- T3 Uptake AccuLite CLIA Test System - 96 Wells — MONOBIND, INC. · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- ARCHITECT — Abbott Laboratories, Inc. · Class II
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- VITROS — Ortho-Clinical Diagnostics · Class I
Cleared under the same submission
K970539 also covers:
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 (4)
- FDA UDI bf180ece-4c45-4387-8aa3-bb65f5e2cb8c 37 fields · synced Jul 10, 2026
- FDA UDI 52bcb894-d550-4f60-923f-ef411b5eb47b 37 fields · synced May 30, 2026
- EUDAMED eb7d24a5-05a7-472e-a4fe-2e47bbc9e589 61 fields · synced Jul 9, 2026
- EUDAMED 7d6801ce-3c91-448a-a110-4fd41059c9b7 61 fields · synced Jul 10, 2026