21 CFR 866.5460 — Haptoglobin, Rhodamine, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5460
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CZZ | Haptoglobin, Rhodamine, Antigen, Antiserum, Control | 2 | 0 | |
| DAB | Haptoglobin, Fitc, Antigen, Antiserum, Control | 2 | 3 | |
| DAD | Haptoglobin, Antigen, Antiserum, Control | 2 | 18 |
Special Controls
CZZ — Haptoglobin, Rhodamine, Antigen, Antiserum, Control
*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.
eCFR
DAB — Haptoglobin, Fitc, Antigen, Antiserum, Control
*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.
eCFR
DAD — Haptoglobin, Antigen, Antiserum, Control
*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.
eCFR
