Human IgD Kit For Use On SpapLus
by The Binding Site 510(k)
Active
510(k) K092450
Overview
The Human IgD Kit is an immunology device designed for use with the SpapLus system. It contains antigens, antiserum, and controls for laboratory testing purposes.
This single-use kit is supplied non-sterile and requires appropriate storage conditions. It is FDA 510(k) cleared with product code CZJ and is intended for immunology laboratory use only.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK092450 | Date28 Dec 2009 | 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- Withdrawn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
- CZJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5510
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from The Binding Site, Ltd.
Questions
What is the Human IgD Kit used for?
The Human IgD Kit is an immunology device designed for laboratory testing purposes when used with the SpapLus system. It contains antigens, antiserum, and controls necessary for immunology laboratory testing.
Is the Human IgD Kit sterile and can it be reused?
The Human IgD Kit is supplied non-sterile and is designed as a single-use kit. It should not be reused and requires appropriate storage conditions to maintain its integrity for laboratory use.
What regulatory approvals does the Human IgD Kit have?
The Human IgD Kit is FDA 510(k) cleared with product code CZJ. It is intended for immunology laboratory use only and has been determined to be substantially equivalent to predicate devices.
What components are included in the Human IgD Kit?
The kit contains antigens, antiserum, and controls specifically formulated for laboratory testing purposes when used with the SpapLus system. These components are essential for conducting accurate immunology tests.