PHYTOHAEMAGGLUTININ
Device Facts
| Record ID | K790239 |
|---|---|
| Device Name | PHYTOHAEMAGGLUTININ |
| Applicant | Pharmacia Fine Chemicals |
| Product Code | KIQ · Hematology |
| Decision Date | Mar 8, 1979 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.2260 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A chromosome culture kit is a device containing the necessary ingredients (e.g., Minimum Essential Media (MEM) of McCoy's 5A culture media, phytohemagglutinin, fetal calf serum, antibiotics, and heparin) used to culture tissues for diagnosis of congenital chromosome abnormalities.
