Identity
- Trade Name
- Titan Gel Immunofix-Plus Kit FDA UDI
- Generic Name
- Protein electrophoresis IVD, kit, electrophoresis FDA UDI
- Model / Reference
- 3067 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52530670 FDA UDI
- 510(k) Number
- K931247 FDA UDI
- FDA Product Code
- DAH 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Protein electrophoresis IVD, kit, electrophoresis
Titan Gel Immunofix-Plus Kit by Helena Laboratories, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Protein electrophoresis IVD, kit, electrophoresis.
- HYDRAGEL 30 PROTEIN(E) — Sebia, Inc. · Class I
- HYDRAGEL 7 LIPOPROTEIN(E) — Sebia, Inc. · Class I
- HYDRAGEL 15 HR ACID VIOLET — Sebia, Inc. · Class I
- HYDRAGEL 5 PROTEINURIE — Sebia, Inc. · Class I
- HYDRAGEL 7 HR ACID VIOLET — Sebia, Inc. · Class I
- HYDRAGEL 15 PROTEINE — Sebia, Inc. · Class I
- HYDRAGEL 30 B1-B2 — Sebia, Inc. · Class I
- HYDRAGEL 15 LIPO + Lp(a) — Sebia, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI 8d931a02-f56e-4bb6-aee4-a4843f1af914 34 fields · synced Jun 9, 2026