Identity
- Trade Name
- Elecsys CA 125 II Assay FDA UDI
- Generic Name
- Cancer antigen 125 (CA125) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Model / Reference
- 11776223161 FDA UDI
Identifiers
- Catalog Number
- 11776223161 FDA UDI
- Primary DI / UDI-DI
- 04015630945795 FDA UDI
- 510(k) Number
- K143534 FDA UDI
- FDA Product Code
- LTK FDA UDI
- GMDN Term
- Cancer antigen 125 (CA125) 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 125 (CA125) IVD, kit, enzyme immunoassay (EIA)
Elecsys CA 125 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 125 (CA125) IVD, kit, enzyme immunoassay (EIA).
- ST AIA-PACK CA 125 — Tosoh Corp. · Class II
Cleared under the same submission
K143534 also covers:
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 a9379bdc-84ad-43e7-b1e3-0a9744e1779d 35 fields · synced May 30, 2026