Human Igg Subclass Liquid Reagent Kits LK001.T
by The Binding Site, Ltd. 510(k)
Active
510(k) K012296
Overview
The Human Igg Subclass Liquid Reagent Kits are a nephelometric method used for the quantification of IgG subclasses 1, 2, 3, and 4 immunoglobulins in serum. These assays are designed to aid in the diagnosis and measurement of immunodeficiency conditions related to the body's ability to resist infections.
This device is supplied as a liquid reagent kit for laboratory use. It has received FDA 510(k) clearance under regulation number 866.5510 and is classified as a Class 2 medical device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK012296 | Date31 Aug 2001 | 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- Withdrawn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
- Full name
- Human Igg Subclass Liquid Reagent Kits, Product Code LK001.T
- 510(k) Number
- FDA Product Code
- CFN
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5510
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent