Identity
- Trade Name
- AccuDiag ™ FDA UDI
- Generic Name
- Multiple rheumatoid arthritis-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AccuDiag ™ Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) The Diagnostic Automation Rheumatoid Factor (RF) Enzyme-Linked Immu-nosorbent Assay (ELISA) is intended for the detection of IgM antibodies in human serum to RF antigen and as an aid in the diagnosis of rheumatoid arthritis. For in vitro diagnostic use. High complexity test. FDA UDI
- Model / Reference
- DACD-2550-1 FDA UDI
- Description
- AccuDiag ™ Rheumatoid factor IVD, kit, enzyme immunoassay (EIA) The Diagnostic Automation Rheumatoid Factor (RF) Enzyme-Linked Immu-nosorbent Assay (ELISA) is intended for the detection of IgM antibodies in human serum to RF antigen and as an aid in the diagnosis of rheumatoid arthritis. For in vitro diagnostic use. High complexity test. FDA UDI
Identifiers
- Catalog Number
- 2550-1 FDA UDI
- Primary DI / UDI-DI
- 00894175000336 FDA UDI
- FDA Product Code
- DHR FDA UDI
- GMDN Term
- Multiple rheumatoid arthritis-associated antibody 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
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: Multiple rheumatoid arthritis-associated antibody IVD, kit, enzyme immunoassay (EIA)
AccuDiag ™ by Diagnostic Automation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple rheumatoid arthritis-associated antibody IVD, kit, enzyme immunoassay (EIA).
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
- Diagnostic Automation, Inc.
Sources (1)
- FDA UDI 629d9d4b-8b36-43a5-b6fe-bc2dd6c5bad1 36 fields · synced May 30, 2026