VENTANA EMA PRIMARY ANDIBODY
Device Facts
| Record ID | K940243 |
|---|---|
| Device Name | VENTANA EMA PRIMARY ANDIBODY |
| Applicant | Ventana Medical Systems, Inc. |
| Product Code | DHF · Immunology |
| Decision Date | Sep 7, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5065 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A human allotypic marker immunological test system is a device that consists of the reagents used to identify by immunochemical techniques the inherited human protein allotypic markers (such as nGm, nA2 m, and Km allotypes) in serum and other body fluids. The identification may be used while studying population genetics.
