Identity
- Trade Name
- TITAN GEL IEP Stain (1 x 10 g powder) FDA UDI
- Generic Name
- Protein electrophoresis IVD, reagent FDA UDI
- Model / Reference
- 3049 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52530490 FDA UDI
- 510(k) Number
- K831603 FDA UDI
- FDA Product Code
- JZR FDA UDI
- GMDN Term
- Protein electrophoresis IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.4900 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, reagent
TITAN GEL IEP Stain (1 x 10 g powder) by Helena Laboratories, Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI 70d55922-0a1d-4162-8994-cd54b7e430db 34 fields · synced Jun 9, 2026