21 CFR 864.9160 — Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
Hematology (HE) · Part 864 Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products · § 864.9160
Identification
Blood group substances of nonhuman origin for in vitro diagnostic use are materials, such as blood group specific substances prepared from nonhuman sources (e.g., pigs, cows, and horses) used to detect, identify, or neutralize antibodies to various human blood group antigens. This generic type of device does not include materials that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.
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 § 864.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| KSX | Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use | 2 | 8 |
Special Controls
KSX — Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
*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 § 864.9.
eCFR
