Identity
- Trade Name
- SPIFE SPE Gel Kit FDA UDI
- Generic Name
- Protein electrophoresis IVD, kit, electrophoresis FDA UDI
- Model / Reference
- 552577 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M5255525770 FDA UDI
- FDA Product Code
- CEF FDA UDI
- GMDN Term
- Protein electrophoresis IVD, kit, electrophoresis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1630 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
Yes
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
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
SPIFE SPE Gel Kit by Helena Laboratories, Corp. — 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
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI d1b448ad-af7f-407d-9b28-8ed1fb574651 33 fields · synced Jun 9, 2026