Identity
- Trade Name
- Elecsys CA 153 II Assay FDA UDI
- Generic Name
- Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 3045838160 FDA UDI
Identifiers
- Catalog Number
- 3045838160 FDA UDI
- Primary DI / UDI-DI
- 04015630934379 FDA UDI
- 510(k) Number
- K010588 FDA UDI
- FDA Product Code
- MOI FDA UDI
- GMDN Term
- Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA) 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, kit, enzyme immunoassay (EIA)
Elecsys CA 153 II Assay 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, kit, enzyme immunoassay (EIA).
- ST AIA-PACK 27.29 — Tosoh Corp. · Class II
- Elecsys CA 15-3 II — Roche Diagnostics Corp. · Class II
- Elecsys CA 15-3 II — Roche Diagnostics Corp. · 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 16dc76cd-b4a3-4686-95a1-ee08fa968806 35 fields · synced May 30, 2026