Identity
- Trade Name
- RHEUMATEX® FDA UDI
- Generic Name
- Multiple rheumatoid arthritis-associated antibody IVD, kit, multiplex FDA UDI
- Model / Reference
- 34S2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10859035006009 FDA UDI
- FDA Product Code
- DHR FDA UDI
- GMDN Term
- Multiple rheumatoid arthritis-associated antibody IVD, kit, multiplex FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5775 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
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple rheumatoid arthritis-associated antibody IVD, kit, multiplex
Rheumatex® by Alere North America, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple rheumatoid arthritis-associated antibody IVD, kit, multiplex.
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
- Alere North America, Llc
Sources (1)
- FDA UDI eb00113a-ca0e-411f-8da6-f3d3cbabb46f 34 fields · synced May 30, 2026