Identity
- Trade Name
- Detector Rheumacol Lex FDA UDI
- Generic Name
- Rheumatoid factor IVD, kit, agglutination FDA UDI
- Device Name
- A rapid color enhanced undiluted latex slide test for the qualitative or semi- quantitative determination of rheumatoid factor in serum FDA UDI
- Model / Reference
- RHLX-50 FDA UDI
- Description
- A rapid color enhanced undiluted latex slide test for the qualitative or semi- quantitative determination of rheumatoid factor in serum FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10722355001521 FDA UDI
- 510(k) Number
- K926569 FDA UDI
- FDA Product Code
- DHR FDA UDI
- GMDN Term
- Rheumatoid factor IVD, kit, agglutination 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
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: Rheumatoid factor IVD, kit, agglutination
Detector Rheumacol Lex by Immunostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Rheumatoid factor IVD, kit, agglutination.
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- VITROS — Ortho-Clinical Diagnostics · Class II
- AIM RF TEST — GERMAINE LABORATORIES, INC. · Class II
- Rheumajet RF 50 TESTS — BIOKIT, S.A. · Class II
- RaPET® RF — STANBIO LABORATORY, L.P. · Class II
Cleared under the same submission
K926569 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Immunostics, Inc.
Sources (1)
- FDA UDI 3c02c3ea-2e17-4290-a6a3-aee43ee1058a 36 fields · synced May 30, 2026