Identity
- Trade Name
- ARCHITECT FDA UDI
- Generic Name
- Cancer antigen 125 (CA125) IVD, control FDA UDI
- Device Name
- ARCHITECT CA 125 II Controls FDA UDI
- Model / Reference
- 02K4511 FDA UDI
- Description
- ARCHITECT CA 125 II Controls FDA UDI
Identifiers
- Catalog Number
- 02K4511 FDA UDI
- Primary DI / UDI-DI
- 00380740145354 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Cancer antigen 125 (CA125) IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
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, control
Architect by Abbott — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cancer antigen 125 (CA125) IVD, control.
- Atellica IM CA 125II MCM — Siemens Healthcare Diagnostics · Class I
- CA-125 Control Slides — BIO SB, INC. · Class I
- IMMULITE® Systems OV Calibration Verification Material OM-MA (CA 125) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- CA-125 Control Slides — BIO SB, INC. · Class I
- ADVIA Centaur® CA 125II MCM — Siemens Healthcare Diagnostics · Class II
- CA-125 control slides — BIO SB, INC. · Class I
- Alinity — Abbott · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Abbott
Sources (1)
- FDA UDI 85c23a30-a32e-436e-95aa-d93fe8243dd9 36 fields · synced Jun 8, 2026