Identity
- Trade Name
- Elecsys CA 125 II FDA UDI
- Generic Name
- Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 07026986190 FDA UDI
Identifiers
- Catalog Number
- 07026986190 FDA UDI
- Primary DI / UDI-DI
- 04015630939633 FDA UDI
- 510(k) Number
- K143534 FDA UDI
- FDA Product Code
- LTK FDA UDI
- GMDN Term
- Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay 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, chemiluminescent immunoassay
Elecsys CA 125 II 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, chemiluminescent immunoassay.
- Alinity — Abbott · Class II
- IMMULITE® 2000 Systems OV OM-MA (CA125) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- ARCHITECT — Abbott · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- IMMULITE®/IMMULITE® 1000 Systems OV OM-MA (CA 125) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- Atellica IM CA 125II — Siemens Healthcare Diagnostics · Class II
- Dimension Vista® Flex® reagent cartridge CA125 — Siemens Healthcare Diagnostics · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI af237563-cb54-425c-84a2-e49f424b0efb 35 fields · synced Jun 1, 2026