ECHO TYPE 11 CF ANTIGEN
Device Facts
| Record ID | K853157 |
|---|---|
| Device Name | ECHO TYPE 11 CF ANTIGEN |
| Applicant | Hillcrest Biologicals |
| Product Code | GNK · Microbiology |
| Decision Date | Nov 7, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3205 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Echovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to echovirus in serum. Additionally, some of these reagents consist of echovirus antisera conjugated with a fluorescent dye used to identify echoviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of echovirus infections and provides epidemiological information on diseases caused by these viruses. Echoviruses cause illnesses such as meningitis (inflammation of the brain and spinal cord membranes), febrile illnesses (accompanied by fever) with or without rash, and the common cold.
