Identity
- Trade Name
- RF FDA UDI
- Generic Name
- Rheumatoid factor IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- The product is a latex agglutination slide test for the qualitative and semi quantitative in vitro determination of Rheumatoid Factor in serum. FDA UDI
- Model / Reference
- RF2716 FDA UDI
- Description
- The product is a latex agglutination slide test for the qualitative and semi quantitative in vitro determination of Rheumatoid Factor in serum. FDA UDI
Identifiers
- Catalog Number
- RF2716 FDA UDI
- Primary DI / UDI-DI
- 05055273205046 FDA UDI
- 510(k) Number
- K961169 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
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, nephelometry/turbidimetry
Rf by Randox Laboratories, Ltd. — 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
- Optilite Rheumatoid Factor Kit — The Binding Site Group · Class II
- Rheumatoid Factors II — Roche Diagnostics Corp. · Class II
- Alinity — Abbott · Class II
- Atellica CH RF — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K961169 also covers:
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
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI 34ab9e7f-9428-456a-bc2a-20303f04deda 37 fields · synced Jun 8, 2026