DAQ · Igg (Fd Fragment Specific), Antigen, Antiserum, Control
Immunology · 21 CFR 866.5540 · Class 1
Overview
| Product Code | DAQ |
|---|---|
| Device Name | Igg (Fd Fragment Specific), Antigen, Antiserum, Control |
| Regulation | 21 CFR 866.5540 |
| Device Class | Class 1 |
| Review Panel | Immunology |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K891299 | MID-LEVEL IGG KIT CAT. NO. 9315 | Helena Laboratories | Mar 22, 1989 | SESE |
Top Applicants
- Helena Laboratories — 1 clearance
