Identity
- Trade Name
- HYDRAGEL LIPO + Lp(a) K20 FDA UDI
- Generic Name
- Protein electrophoresis IVD, kit, electrophoresis FDA UDI
- Device Name
- Lipoprotein + Lp(a) using K20 FDA UDI
- Model / Reference
- 3007 FDA UDI
- Description
- Lipoprotein + Lp(a) using K20 FDA UDI
Identifiers
- Catalog Number
- 3007 FDA UDI
- Primary DI / UDI-DI
- 03607360030073 FDA UDI
- FDA Product Code
- JHO FDA UDI
- GMDN Term
- Protein electrophoresis IVD, kit, electrophoresis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1475 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
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: Protein electrophoresis IVD, kit, electrophoresis
HYDRAGEL LIPO + Lp(a) K20 by Sebia, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Sebia, Inc.
Sources (1)
- FDA UDI b5f26740-d525-4299-b623-5f0609c411a4 35 fields · synced May 30, 2026