P1 BLOOD GROUP SUBSTANCE
Device Facts
| Record ID | K771488 |
|---|---|
| Device Name | P1 BLOOD GROUP SUBSTANCE |
| Applicant | Ortho Diagnostics, Inc. |
| Product Code | KSX · Hematology |
| Decision Date | Nov 8, 1977 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.9160 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
