MID-LEVEL IGG KIT CAT. NO. 9315
Device Facts
| Record ID | K891299 |
|---|---|
| Device Name | MID-LEVEL IGG KIT CAT. NO. 9315 |
| Applicant | Helena Laboratories |
| Product Code | DAQ · Immunology |
| Decision Date | Mar 22, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5540 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An immunoglobulin G (Fd fragment specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the amino terminal (antigen-binding) end (Fd fragment) of the heavy chain (a subunit) of the immunoglobulin antibody molecule in serum. Measurement of immunoglobulin G Fd fragments aids in the diagnosis of plasma antibody-forming cell abnormalities.
