Identity
- Trade Name
- ADVIA Centaur® T4 FDA UDI
- Generic Name
- Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- T4 Total - CENTAUR - RGT - 100 tests FDA UDI
- Model / Reference
- 10309960 FDA UDI
- Description
- T4 Total - CENTAUR - RGT - 100 tests FDA UDI
Identifiers
- Catalog Number
- 110735 FDA UDI
- Primary DI / UDI-DI
- 00630414177045 FDA UDI
- 510(k) Number
- K905532 FDA UDI
- FDA Product Code
- CDX FDA UDI
- GMDN Term
- Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1700 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: Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® T4 by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay.
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- Alinity — ABBOTT IRELAND · Class II
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- IMMULITE® 2000 Systems TT4 Total T4 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
K905532 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 7c9c7b2f-dea0-4c70-850d-346ea4dc6e00 37 fields · synced May 30, 2026