Identity
- Trade Name
- IT/IF Control FDA UDI
- Generic Name
- Protein electrophoresis IVD, control FDA UDI
- Device Name
- Control for the detection and characterization of monoclonal proteins in human serum and urine FDA UDI
- Model / Reference
- 4788 FDA UDI
- Description
- Control for the detection and characterization of monoclonal proteins in human serum and urine FDA UDI
Identifiers
- Catalog Number
- 4788 FDA UDI
- Primary DI / UDI-DI
- 03607360023006 FDA UDI
- FDA Product Code
- DFH FDA UDIDEH FDA UDICFF FDA UDICEF FDA UDIJJY FDA UDI
- GMDN Term
- Protein electrophoresis IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5550 FDA UDI866.5510 FDA UDI862.1630 FDA UDI862.1660 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
Yes
FDA UDI
Category: Protein electrophoresis IVD, control
IT/IF Control by Sebia, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Sebia, Inc.
Sources (1)
- FDA UDI f140dcb9-115b-4312-b509-c2ddc3d3d0b3 35 fields · synced Jun 8, 2026