Identity
- Trade Name
- Amido Black Protein Stain (powder) FDA UDI
- Generic Name
- Protein electrophoresis IVD, reagent FDA UDI
- Model / Reference
- 3048 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M52530480 FDA UDI
- 510(k) Number
- K972274 FDA UDI
- FDA Product Code
- CEF FDA UDI
- GMDN Term
- Protein electrophoresis IVD, reagent 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
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
Amido Black Protein Stain (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
K972274 also covers:
- Neutral Density Densitometer Control for SPIFE 4000 — Helena Laboratories, Corp.
- QUICKGEL MODIFIED APPLICATOR BLADES AND DEEP WELL CUPS — Helena Laboratories, Corp.
- QUICKGEL SPE Gel Kit — Helena Laboratories, Corp.
- SPIFE 3000 w/ New Pump & Valve (110V) — Helena Laboratories, Corp.
- SPIFE 3000 w/ New Pump & Valve (220V) — Helena Laboratories, Corp.
- SPIFE 3000, "CE 2011" (120V) — Helena Laboratories, Corp.
- SPIFE 3000, "CE 2011" (230V) — Helena Laboratories, Corp.
- SPIFE 4000, Windows 7 (100V) — Helena Laboratories, Corp.
- SPIFE 4000, Windows 7 (110V) — Helena Laboratories, Corp.
- SPIFE 4000, Windows 7 (220V) — Helena Laboratories, Corp.
- SPIFE Nexus (120/230V) — Helena Laboratories, Corp.
- SPIFE Touch (230V) — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Helena Laboratories, Corp.
Sources (1)
- FDA UDI a3ab87f6-b38b-4821-924e-90ee4c8b7d83 34 fields · synced Jun 9, 2026