21 CFR 864.9300 — System, Test, Combs, Automated
Hematology (HE) · Part 864 Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products · § 864.9300
Identification
An automated Coombs test system is a device used to detect and identify antibodies in patient sera or antibodies bound to red cells. The Coombs test is used for the diagnosis of hemolytic disease of the newborn, and autoimmune hemolytic anemia. The test is also used in crossmatching and in investigating transfusion reactions and drug-induced red cell sensitization.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KSM | System, Test, Combs, Automated | 2 | 0 |
