Diesse RF Test Kit
by Marvic Interpharma, Inc. 510(k)
Active
510(k) K854222
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK854222 | Date6 Feb 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DHR
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5775
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Diesse RF Test Kit is a laboratory test system designed to detect rheumatoid factor in patient samples. It is classified as a Test, Rheumatoid Factor system and is used to support the diagnosis of autoimmune conditions by identifying the presence of rheumatoid factor antibodies.
The kit is supplied as a complete test system for in‑vitro use in clinical laboratories. It received FDA 510(k) clearance (K854222) as a Class II device with product code DHR, indicating it is substantially equivalent to a predicate device. The kit is intended for single‑use per patient sample and is stored according to standard laboratory conditions.
Other devices from Marvic Interpharma, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Diesse RF Test Kit used for?
The Diesse RF Test Kit is a laboratory test system designed to detect rheumatoid factor in patient samples. It supports the diagnosis of autoimmune conditions by identifying the presence of rheumatoid factor antibodies in clinical laboratory settings.
How is the Diesse RF Test Kit supplied?
The kit is supplied as a complete test system for in-vitro use in clinical laboratories. It includes all necessary components for detecting rheumatoid factor in patient samples according to standard laboratory procedures.
Is the Diesse RF Test Kit single-use or reusable?
The Diesse RF Test Kit is intended for single-use per patient sample. This ensures test accuracy and prevents cross-contamination between different patient samples in the laboratory setting.
What is the regulatory status of the Diesse RF Test Kit?
The Diesse RF Test Kit received FDA 510(k) clearance (K854222) as a Class II device with product code DHR. It is classified as substantially equivalent to a predicate device and is intended for in-vitro diagnostic use in clinical laboratories.