Identity
- Trade Name
- Elecsys CA 153 II CalSet FDA UDI
- Generic Name
- Cancer antigen 15-3 (CA15-3) IVD, calibrator FDA UDI
- Model / Reference
- 3045846122 FDA UDI
Identifiers
- Catalog Number
- 3045846122 FDA UDI
- Primary DI / UDI-DI
- 04015630918225 FDA UDI
- 510(k) Number
- K001468 FDA UDI
- FDA Product Code
- MOI FDA UDI
- GMDN Term
- Cancer antigen 15-3 (CA15-3) IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.6010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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: Cancer antigen 15-3 (CA15-3) IVD, calibrator
Elecsys CA 153 II CalSet by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cancer antigen 15-3 (CA15-3) IVD, calibrator.
- ARCHITECT — Abbott · Class II
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- ADVIA Centaur® Systems, ACS:180® Systems CA 15-3® Calibrator — Siemens Healthcare Diagnostics · Class II
- Alinity — Abbott · Class II
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 08cc66c9-e5bd-401b-8d14-61c2e00e6180 35 fields · synced Jun 8, 2026