21 CFR 866.5490 — Hemopexin, Rhodamine, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5490
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.
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 |
|---|---|---|---|---|
| CZR | Hemopexin, Rhodamine, Antigen, Antiserum, Control | 2 | 0 | |
| CZT | Hemopexin, Fitc, Antigen, Antiserum, Control | 2 | 0 | |
| CZX | Hemopexin, Antigen, Antiserum, Control | 2 | 3 |
Special Controls
CZR — Hemopexin, 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
CZT — Hemopexin, 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
CZX — Hemopexin, 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
