HEMOPEXIN NEPHELOMETRIC ASSAYS
Device Facts
| Record ID | K780250 |
|---|---|
| Device Name | HEMOPEXIN NEPHELOMETRIC ASSAYS |
| Applicant | Kallestad Laboratories, Inc. |
| Product Code | CZX · Immunology |
| Decision Date | Feb 28, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5490 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A hemopexin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the hemopexin (a serum protein that binds heme, a component of hemoglobin) in serum. Measurement of hemopexin aids in the diagnosis of various hematologic disorders, such as hemolytic anemia (anemia due to shortened in vivo survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
