Rit Liver, Kidney, Stomach Ifa Kit
by The Binding Site, Ltd. 510(k)
Active
510(k) K955431
Overview
The Rit Liver, Kidney, Stomach Ifa Kit is an indirect immunofluorescent antigen control device. It is used for the detection of multiple autoantibodies.
This device is classified as a Class II medical device under regulation number 866.5660 and product code DBL. It has received FDA 510(k) clearance under K955431.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK955431 | Date23 Apr 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DBL
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5660
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from The Binding Site, Ltd.
Questions
What is the primary purpose of the Rit Liver, Kidney, Stomach IFA Kit?
This device functions as an indirect immunofluorescent antigen control. It is specifically designed to assist in the detection of multiple autoantibodies within a clinical laboratory setting.
How is this device classified for regulatory purposes?
The kit is classified as a Class II medical device under regulation number 866.5660, which pertains to multiple autoantibody, indirect immunofluorescent, antigen, control devices. It has received FDA 510(k) clearance under submission number K955431.
What is the product code associated with this kit?
The device is identified by product code DBL, which corresponds to its classification as an indirect immunofluorescent antigen control device for immunology applications.