MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT
Device Facts
| Record ID | K852932 |
|---|---|
| Device Name | MEASLES-COMPLEMENT FIX ANTIGEN & NEGATIVE CLT |
| Applicant | Microbix Biosystems, Inc. |
| Product Code | GRF · Microbiology |
| Decision Date | Nov 12, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3520 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Rubeola (measles) virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubeola virus in serum. The identification aids in the diagnosis of measles and provides epidemiological information on the disease. Measles is an acute, highly infectious disease of the respiratory and reticuloendothelial tissues, particularly in children, characterized by a confluent and blotchy rash.
