Identity
- Trade Name
- Detector Rheumacol FDA UDI
- Generic Name
- Rheumatoid factor IVD, kit, agglutination FDA UDI
- Device Name
- A rapid color enhanced hemagglutination slide test for the detection of rheumatoid factor in serum or synovial fluid FDA UDI
- Model / Reference
- RH-100 FDA UDI
- Description
- A rapid color enhanced hemagglutination slide test for the detection of rheumatoid factor in serum or synovial fluid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10722355001514 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 by Immunostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rheumatoid factor IVD, kit, agglutination.
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- Sure-Vue — FISHER SCIENTIFIC COMPANY L.L.C. · Class II
- 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
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
- Immunostics, Inc.
Sources (1)
- FDA UDI 1f7d9744-8efc-4324-ba4d-969aa0db2c26 35 fields · synced May 30, 2026