GUINEA PIG COMPLEMENT VIRUS ANTIBODY
Device Facts
| Record ID | K812369 |
|---|---|
| Device Name | GUINEA PIG COMPLEMENT VIRUS ANTIBODY |
| Applicant | Dutchland Laboratories, Inc. |
| Product Code | KTQ · Immunology |
| Decision Date | Sep 8, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.4100 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A complement reagent is a device that consists of complement, a naturally occurring serum protein from any warm-blooded animal such as guinea pigs, that may be included as a component part of serological test kits used in the diagnosis of disease.
