Identity
- Trade Name
- ProC® Control Plasma FDA UDI
- Generic Name
- Protein C IVD, control FDA UDI
- Device Name
- Assayed control to monitor the performance of Factor V Leiden assay in the pathological range FDA UDI
- Model / Reference
- 10446097 FDA UDI
- Description
- Assayed control to monitor the performance of Factor V Leiden assay in the pathological range FDA UDI
Identifiers
- Catalog Number
- OQKE19 FDA UDI
- Primary DI / UDI-DI
- 00842768007774 FDA UDI
- 510(k) Number
- K042333 FDA UDI
- FDA Product Code
- GGN FDA UDI
- GMDN Term
- Protein C IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5425 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
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: Protein C IVD, control
ProC® Control Plasma by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Protein C IVD, control.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 9d5fc576-9946-48c5-9522-3f0a78d4aa67 37 fields · synced May 30, 2026