Identity
- Trade Name
- AIA-PACK CA 125 Calibrator Set FDA UDI
- Generic Name
- Cancer antigen 125 (CA125) IVD, calibrator FDA UDI
- Model / Reference
- N/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560189211148 FDA UDI
- FDA Product Code
- LTK FDA UDI
- GMDN Term
- Cancer antigen 125 (CA125) 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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, calibrator
AIA-PACK CA 125 Calibrator Set by Tosoh Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cancer antigen 125 (CA125) IVD, calibrator.
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- Elecsys CA 125 II CalSet II — Roche Diagnostics Corp. · Class II
- Atellica IM CA 125II Calibrator — Siemens Healthcare Diagnostics · 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
- Tosoh Corp.
Sources (1)
- FDA UDI 2ac8a388-1473-4af6-924c-075ee2d9549b 34 fields · synced Jun 1, 2026