Identity
- Trade Name
- AccuDiag™ FDA UDI
- Generic Name
- Rheumatoid factor IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- AccuDiag™ RF Latex Test Kit For the qualitative and semi-quantitative measurement of RF in human serum. FDA UDI
- Model / Reference
- DACD320-100 FDA UDI
- Description
- AccuDiag™ RF Latex Test Kit For the qualitative and semi-quantitative measurement of RF in human serum. FDA UDI
Identifiers
- Catalog Number
- 320-100 FDA UDI
- Primary DI / UDI-DI
- 00894175000381 FDA UDI
- FDA Product Code
- DHR FDA UDI
- GMDN Term
- Rheumatoid factor IVD, kit, nephelometry/turbidimetry 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
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, nephelometry/turbidimetry
AccuDiag™ by Diagnostic Automation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rheumatoid factor IVD, kit, nephelometry/turbidimetry.
- Rheumatoid Factors II — Roche Diagnostics Corp. · Class II
- Tinaquant RF II — Roche Diagnostics Corp. · Class II
- Yumizen C1200 Rheumatoid Factor — Horiba Abx · Class II
- Rheumatoid Factors II — Roche Diagnostics Corp. · Class II
- RF — Randox Laboratories, Ltd. · Class II
- Optilite Rheumatoid Factor Kit — The Binding Site Group · Class II
- Rheumatoid Factors II — Roche Diagnostics Corp. · Class II
- Alinity — Abbott · 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
- Diagnostic Automation, Inc.
Sources (1)
- FDA UDI 1470b6ce-2049-4ea7-896b-6da9ec829078 36 fields · synced May 30, 2026