ADVIA Centaur® CA 15-3® MCM
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ADVIA Centaur® CA 15-3® EUDAMEDFDA UDIADVIA Centaur® CA 15-3® MCM FDA UDI
- Generic Name
- Cancer antigen 15-3 (CA15-3) IVD, control FDA UDICancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_C_KIT_CA 15-3 EUDAMEDCA15-3 master curve material - CENTAUR - CONS FDA UDICA 15-3 - CENTAUR - RGT - 500 tests FDA UDI
- Model / Reference
- 10312831 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_C_KIT_CA 15-3 EUDAMED10330854 FDA UDI
- Description
- CA15-3 master curve material - CENTAUR - CONS FDA UDICA 15-3 - CENTAUR - RGT - 500 tests FDA UDI
Identifiers
- Catalog Number
- 128531 FDA UDI128535 FDA UDI
- Primary DI / UDI-DI
- 00630414461328 EUDAMEDFDA UDI00630414461281 FDA UDI
- Basic UDI-DI
- 0405686901801VL EUDAMED
- Unit of Use DI
- 00630414003481 EUDAMED
- 510(k) Number
- K012357 FDA UDI
- FDA Product Code
- MOI FDA UDI
- EMDN Code
- W0102030102 CANCER ANTIGEN 15-3 EUDAMED
- GMDN Term
- Cancer antigen 15-3 (CA15-3) IVD, control FDA UDICancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 866.6010 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: Cancer antigen 15-3 (CA15-3) IVD, control
ADVIA Centaur® CA 15-3® MCM by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cancer antigen 15-3 (CA15-3) IVD, control.
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- ARCHITECT — Abbott · Class I
- Atellica IM CA 15-3 MCM — Siemens Healthcare Diagnostics · Class I
Cleared under the same submission
K012357 also covers:
- ADVIA Centaur® CA 15-3® — Siemens Healthcare Diagnostics
- ADVIA Centaur® Systems, ACS:180® Systems CA 15-3® Calibrator — Siemens Healthcare Diagnostics
- Atellica IM CA 15-3 — Siemens Healthcare Diagnostics
- Atellica IM CA 15-3 — Siemens Healthcare Diagnostics
- Atellica IM CA 15-3 — Siemens Healthcare Diagnostics
- Atellica IM CA 15-3 MCM — Siemens Healthcare Diagnostics
- Atellica IM CA 15-3® Calibrator — 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 (3)
- FDA UDI 74b5260f-04ea-4102-9750-ada2a6b6fa44 37 fields · synced Jul 9, 2026
- FDA UDI 3bbcf668-3632-4a39-96a1-175570f3334b 37 fields · synced May 30, 2026
- EUDAMED 9be3fb96-590f-4fcc-97b0-09e7406ab481 61 fields · synced Jul 9, 2026