Identity
- Trade Name
- Rheumatoid Factor IgG ELISA FDA UDI
- Generic Name
- Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Rheumatoid Factor IgG ELISA is a test system for the quantitative measurement of IgG class rheumatoid factor in human serum or plasma. FDA UDI
- Model / Reference
- EIA-3584 FDA UDI
- Description
- Rheumatoid Factor IgG ELISA is a test system for the quantitative measurement of IgG class rheumatoid factor in human serum or plasma. FDA UDI
Identifiers
- Catalog Number
- EIA-3584 FDA UDI
- Primary DI / UDI-DI
- 04048474035841 FDA UDI
- FDA Product Code
- DHR FDA UDI
- GMDN Term
- Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) 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
No
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
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: Rheumatoid factor IVD, kit, enzyme immunoassay (EIA)
Rheumatoid Factor IgG ELISA by DRG Instruments Gesellschaft mit beschränkter Haftung — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Rheumatoid factor IVD, kit, enzyme immunoassay (EIA).
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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
Sources (1)
- FDA UDI 52a8e993-d4ba-47d2-a718-6f7bc9e77136 36 fields · synced May 30, 2026