REAGENT CONFIDENCE SERA
Device Facts
| Record ID | K771814 |
|---|---|
| Device Name | REAGENT CONFIDENCE SERA |
| Applicant | Ortho Diagnostics, Inc. |
| Product Code | KSF · Hematology |
| Decision Date | Nov 7, 1977 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.9650 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A quality control kit for blood banking reagents is a device that consists of sera, cells, buffers, and antibodies used to determine the specificity, potency, and reactivity of the cells and reagents used for blood banking.
