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IMMULITE® Systems OV Calibration Verification Material OM-MA (CA 125)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- IMMULITE® Systems OV Calibration Verification Material OM-MA (CA 125) FDA UDI
- Generic Name
- Cancer antigen 125 (CA125) IVD, control FDA UDI
- Device Name
- CA 125 CVM - IMMULITE - CONS FDA UDI
- Model / Reference
- 10373698 FDA UDI
- Description
- CA 125 CVM - IMMULITE - CONS FDA UDI
Identifiers
- Catalog Number
- LOPCVM FDA UDI
- Primary DI / UDI-DI
- 00630414971308 FDA UDI
- 510(k) Number
- K132739 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
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
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, control
IMMULITE® Systems OV Calibration Verification Material OM-MA (CA 125) by Siemens Healthcare Diagnostics Products Ltd — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Cancer antigen 125 (CA125) IVD, control.
- Atellica IM CA 125II MCM — Siemens Healthcare Diagnostics · Class I
- Alinity — Abbott · Class I
- CA-125 Control Slides — BIO SB, INC. · Class I
- CA-125 Control Slides — BIO SB, INC. · Class I
- ADVIA Centaur® CA 125II MCM — Siemens Healthcare Diagnostics · Class II
- ARCHITECT — Abbott · Class I
- CA-125 control slides — BIO SB, INC. · Class I
Cleared under the same submission
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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI c1ddfe73-bb5d-479d-9b3a-28cdeaca68be 37 fields · synced May 30, 2026