HAPTOGLOBIN IMMUNOLOGICAL TEST KIT
Device Facts
| Record ID | K913670 |
|---|---|
| Device Name | HAPTOGLOBIN IMMUNOLOGICAL TEST KIT |
| Applicant | The Binding Site, Ltd. |
| Product Code | DAB · Immunology |
| Decision Date | Dec 9, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5460 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.
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.
