GOE · Antisera, Fluorescent, Poliovirus 1-3
Microbiology · 21 CFR 866.3405 · Class 1
Overview
| Product Code | GOE |
|---|---|
| Device Name | Antisera, Fluorescent, Poliovirus 1-3 |
| Regulation | 21 CFR 866.3405 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K940473 | ENTEROVIRUS 71 MONOCLONAL ANTIBODY | Chemicon Intl., Inc. | Sep 12, 1995 | SESE |
| K940034 | POLIOVIRUS 2 MONOCLONAL ANTIBODY | Light Diagnostics | Sep 12, 1995 | SESE |
| K940027 | ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES | Chemicon Intl., Inc. | Sep 12, 1995 | SESE |
| K940026 | POLIOVIRUS BLEND MONOCLONAL ANTIBODIES | Light Diagnostics | Sep 12, 1995 | SESE |
| K940017 | POLIOVIRUS 3 MONOCLONAL ANTIBODY | Light Diagnostics | Sep 12, 1995 | SESE |
| K940363 | ENTEROVIRUS 70 MONCLONAL ANTIBODY | Light Diagnostics | Sep 8, 1995 | SESE |
| K940018 | POLIOVIRUS 1 MONOCLONAL ANTIBODY | Light Diagnostics | Sep 8, 1995 | SESE |
Top Applicants
- Light Diagnostics — 5 clearances
- Chemicon Intl., Inc. — 2 clearances
