Identity
- Trade Name
- Unitron Brand FDA UDI
- Generic Name
- Immunoglobulin A subclass (IgA subclass) IVD, control FDA UDI
- Device Name
- Moxi B5-RS Left (platinum) FDA UDI
- Model / Reference
- 050-6474-P6 FDA UDI
- Description
- Moxi B5-RS Left (platinum) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07613389527353 FDA UDI
- FDA Product Code
- OSM FDA UDI
- GMDN Term
- Immunoglobulin A subclass (IgA subclass) IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3305 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Immunoglobulin A subclass (IgA subclass) IVD, control
Unitron Brand by Sonova AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Immunoglobulin A subclass (IgA subclass) IVD, control.
- IgA Control Slides — BIO SB, INC. · Class I
- Unitron Brand — Sonova AG · Class II
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
- Sonova AG
Sources (1)
- FDA UDI e5aa8384-051a-4184-a3b9-bb39137df453 33 fields · synced May 30, 2026