Identity
- Trade Name
- SPIFE IFE Applicator Kit FDA UDI
- Generic Name
- Protein electrophoresis IVD, kit, electrophoresis FDA UDI
- Model / Reference
- 552124 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M5255521240 FDA UDI
- 510(k) Number
- K973040 FDA UDI
- FDA Product Code
- CFF FDA UDI
- GMDN Term
- Protein electrophoresis IVD, kit, electrophoresis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Protein electrophoresis IVD, kit, electrophoresis
SPIFE IFE Applicator Kit by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Protein electrophoresis IVD, kit, electrophoresis.
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Cleared under the same submission
K973040 also covers:
- Blade Applicator Kit, 12 Sample — Helena Laboratories, Corp.
- Blade Applicator Kit, 18 Sample — Helena Laboratories, Corp.
- Blade Applicator Kit, 18 Sample — Helena Laboratories, Corp.
- Blade Applicator Kit, 18 Sample — Helena Laboratories, Corp.
- QuickGel Disposable IFE Sample Cup Strips — Helena Laboratories, Corp.
- QuickGel IFE Antisera Kit — Helena Laboratories, Corp.
- QuickGel IFE Applicator Blades and Sample Cups — Helena Laboratories, Corp.
- QuickGel IFE Blotter A and Templates — Helena Laboratories, Corp.
- QuickGel IFE Gel Kit — Helena Laboratories, Corp.
- SPIFE 4000 IFE Antisera Kit — Helena Laboratories, Corp.
- SPIFE 4000 IFE Gel Kit — Helena Laboratories, Corp.
- SPIFE ImmunFix-15 Urine Accessory Kit — Helena Laboratories, Corp.
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
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI fb06fea0-2698-4d4d-be11-e249fbc2a509 34 fields · synced Jun 9, 2026