21 CFR 866.5620 — Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control
Immunology (IM) · Part 866 Subpart F—Immunological Test Systems · § 866.5620
Identification
An alpha-2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.
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 the limitations in § 866.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DDT | Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control | 2 | 0 | |
| DDY | Alpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control | 2 | 1 | |
| DEB | Alpha-2-Macroglobulin, Antigen, Antiserum, Control | 2 | 13 |
Special Controls
DDT — Alpha-2-Macroglobulin, 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 the limitations in § 866.9.
eCFR
DDY — Alpha-2-Macroglobulin, 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 the limitations in § 866.9.
eCFR
DEB — Alpha-2-Macroglobulin, 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 the limitations in § 866.9.
eCFR
