ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL
Device Facts
| Record ID | K874375 |
|---|---|
| Device Name | ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL |
| Applicant | Abbott Laboratories |
| Product Code | LIQ · Microbiology |
| Decision Date | Dec 10, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3405 |
| Device Class | Class 1 |
Regulatory Classification
Identification
Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity.
