ORTHO ANTIBODY ENHANCEMENT SOLUTION
Device Facts
| Record ID | K791791 |
|---|---|
| Device Name | ORTHO ANTIBODY ENHANCEMENT SOLUTION |
| Applicant | Ortho Diagnostics, Inc. |
| Product Code | KSG · Hematology |
| Decision Date | Oct 11, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.9600 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Potentiating media for in vitro diagnostic use are media, such as bovine albumin, that are used to suspend red cells and to enhance cell reactions for antigen-antibody testing.
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.
