RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600
Device Facts
| Record ID | K891990 |
|---|---|
| Device Name | RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 |
| Applicant | Clinical Sciences, Inc. |
| Product Code | LJB · Microbiology |
| Decision Date | Jun 15, 1989 |
| 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.
