ADVIA Centaur® CA 19-9™
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- ADVIA Centaur® CA 19-9™ EUDAMEDFDA UDI
- Generic Name
- Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- IVDR_67_TTN_DUB-C_C_KIT_CA 19-9 EUDAMEDCA 19-9 - CENTAUR - RGT - 250 tests FDA UDI
- Model / Reference
- 10491244 EUDAMEDFDA UDIIVDR_67_TTN_DUB-C_C_KIT_CA 19-9 EUDAMED
- Description
- CA 19-9 - CENTAUR - RGT - 250 tests FDA UDI
Identifiers
- Catalog Number
- 10491244 FDA UDI
- Primary DI / UDI-DI
- 00630414574028 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686900806VP EUDAMED
- 510(k) Number
- K031393 FDA UDI
- FDA Product Code
- NIG FDA UDI
- EMDN Code
- W0102030103 CANCER ANTIGEN 19-9 EUDAMED
- GMDN Term
- Cancer antigen 19-9 (CA19-9) 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
Yes
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 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® CA 19-9™ by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay.
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Cleared under the same submission
K031393 also covers:
- ADVIA Centaur® CA 19-9 DIL — Siemens Healthcare Diagnostics
- ADVIA Centaur® CA 19-9 MCM — Siemens Healthcare Diagnostics
- ADVIA Centaur® CA 19-9™ — Siemens Healthcare Diagnostics
- ADVIA Centaur® CA 19-9™ DIL — Siemens Healthcare Diagnostics
- Atellica IM CA 19-9 — Siemens Healthcare Diagnostics
- Atellica IM CA 19-9 — Siemens Healthcare Diagnostics
- Atellica IM CA 19-9 — Siemens Healthcare Diagnostics
- Atellica IM CA 19-9 DIL — Siemens Healthcare Diagnostics
- Atellica IM CA 19-9 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 e4c8eacd-2063-4eb3-9daf-68b6af2aebac 37 fields · synced Jul 9, 2026
- EUDAMED 2a644d45-a5c5-4c93-805c-3d933ecfd17b 61 fields · synced Jul 9, 2026