Identity
- Trade Name
- RaPET® RF FDA UDI
- Generic Name
- Rheumatoid factor IVD, kit, agglutination FDA UDI
- Device Name
- Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Rheumatoid Factor in non-diluted serum. FDA UDI
- Model / Reference
- 1155-100 FDA UDI
- Description
- Latex agglutination slide test for the Qualitative and Semi-quantitative determination of Rheumatoid Factor in non-diluted serum. FDA UDI
Identifiers
- Catalog Number
- 1155-100 FDA UDI
- Primary DI / UDI-DI
- 00657498001271 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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, agglutination
RaPET® RF by Stanbio Laboratory, L.p. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rheumatoid factor IVD, kit, agglutination.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- RapiTex® RF — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- ASI RF Direct Slide Test — Arlington Scientific, Inc. · Class II
- 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
- Detector Rheumacol — IMMUNOSTICS, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stanbio Laboratory, L.p.
Sources (1)
- FDA UDI 3ab51a2e-811e-4cb2-a3ab-d892066ef6f8 36 fields · synced May 30, 2026