ADVIA Centaur® HCY
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ADVIA Centaur® HCY EUDAMEDFDA UDI
- Generic Name
- Homocysteine IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_B_KIT_HCY EUDAMEDHomocystein - CENTAUR - RGT - 100 tests FDA UDIHomocystein - CENTAUR - RGT - 500 tests FDA UDI
- Model / Reference
- 10310375 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_B_KIT_HCY EUDAMED10310374 FDA UDI
- Description
- Homocystein - CENTAUR - RGT - 100 tests FDA UDIHomocystein - CENTAUR - RGT - 500 tests FDA UDI
Identifiers
- Catalog Number
- 124577 FDA UDI124578 FDA UDI
- Primary DI / UDI-DI
- 00630414468181 EUDAMEDFDA UDI00630414468174 FDA UDI
- Basic UDI-DI
- 0405686901615VM EUDAMED
- 510(k) Number
- K013406 FDA UDI
- FDA Product Code
- LPS FDA UDI
- EMDN Code
- W01021307 HOMOCYSTEINE EUDAMED
- GMDN Term
- Homocysteine IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1377 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: Homocysteine IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® HCY by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Homocysteine IVD, kit, chemiluminescent immunoassay.
- ARCHITECT — Abbott · Class II
- IMMULITE® 2000 Systems HCY Homocysteine — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- IMMULITE®/IMMULITE® 1000 Systems HCY Homocysteine — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Alinity — Abbott · Class II
- Atellica IM HCY — Siemens Healthcare Diagnostics · Class II
- Atellica IM HCY — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K013406 also covers:
- ADVIA Centaur® HCY DIL — Siemens Healthcare Diagnostics
- ADVIA Centaur® HCY MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems HCY Calibrator — Siemens Healthcare Diagnostics
- Atellica IM HCY — Siemens Healthcare Diagnostics
- Atellica IM HCY — Siemens Healthcare Diagnostics
- Atellica IM HCY Calibrator — Siemens Healthcare Diagnostics
- Atellica IM HCY DIL — Siemens Healthcare Diagnostics
- Atellica IM HCY 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (3)
- FDA UDI d00c0d01-aff7-48d3-a97a-bfcda12d29eb 37 fields · synced Jul 10, 2026
- FDA UDI 921ba277-3c5f-474a-9101-fbde1d491848 37 fields · synced May 30, 2026
- EUDAMED cc588b67-c643-4f69-9ad0-f39f72423562 61 fields · synced Jul 10, 2026