← Back to catalogue
RHEUMATOID FACTOR LINEARITY VERIFIERS (For Roche Systems) (RFLV)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- RHEUMATOID FACTOR LINEARITY VERIFIERS (For Roche Systems) (RFLV) FDA UDI
- Generic Name
- Rheumatoid factor IVD, control FDA UDI
- Device Name
- Rheumatoid Factor Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Rheumatoid Factor (RF). FDA UDI
- Model / Reference
- LV10343 FDA UDI
- Description
- Rheumatoid Factor Linearity Verifiers are an in vitro diagnostic product used to assess the linearity of Roche Systems for Rheumatoid Factor (RF). FDA UDI
Identifiers
- Catalog Number
- LV10343 FDA UDI
- Primary DI / UDI-DI
- 05055273216240 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Rheumatoid factor IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
Yes
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, control
RHEUMATOID FACTOR LINEARITY VERIFIERS (For Roche Systems) (RFLV) by Randox Laboratories, Ltd. — Class I — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Rheumatoid factor IVD, control.
- IMMUNO-TROL — THERADIAG SA
- Optilite® Rheumatoid Factor Control Pack — The Binding Site Group · Class I
- N/T Rheumatology Control SL/2 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Liquichek — Bio-Rad Laboratories · Class II
- Audit MicroControls Linearity LQ RF/CRP — Aalto Scientific, Ltd.
- Liquichek — Bio-Rad Laboratories · Class II
- Liquichek — Bio-Rad Laboratories · Class II
- N/T Rheumatology Control SL/1 — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Randox Laboratories, Ltd.
Sources (1)
- FDA UDI b3dbc262-22fc-4c52-900d-dfd02d316c3b 36 fields · synced Jun 8, 2026