GNM · Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6
Microbiology · 21 CFR 866.3145 · Class 1
Overview
| Product Code | GNM |
|---|---|
| Device Name | Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6 |
| Regulation | 21 CFR 866.3145 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Coxsackievirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to coxsackievirus in serum. Additionally, some of these reagents consist of coxsackievirus antisera conjugated with a fluorescent dye that are used to identify coxsackievirus from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of coxsackievirus infections and provides epidemiological information on diseases caused by these viruses. Coxsackieviruses produce a variety of infections, including common colds, meningitis (inflammation of brain and spinal cord membranes), herpangina (brief fever accompanied by ulcerated lesions of the throat), and myopericarditis (inflammation of heart tissue).
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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K940472 | COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY | Chemicon Intl., Inc. | Sep 8, 1995 | SESE |
| K940471 | COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES | Chemicon Intl., Inc. | Sep 8, 1995 | SESE |
| K936254 | COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY | Light Diagnostics | Sep 8, 1995 | SESE |
| K936253 | COXSACKIEVIRUS B4 MONOCLONAL ANTIBODY | Light Diagnostics | Sep 8, 1995 | SESE |
| K936252 | COXSACKIEVIRUS B@ MONOCLONAL ANTIBODY | Light Diagnostics | Sep 8, 1995 | SESE |
| K936251 | COXSACKIEVIRUS B3 MONOCLONAL ANTIBODY | Light Diagnostics | Sep 8, 1995 | SESE |
| K936145 | COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY | Chemicon Intl., Inc. | Sep 8, 1995 | SESE |
| K936089 | COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY | Chemicon Intl., Inc. | Sep 8, 1995 | SESE |
| K936073 | ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS | Chemicon Intl., Inc. | Sep 8, 1995 | SESE |
Top Applicants
- Chemicon Intl., Inc. — 5 clearances
- Light Diagnostics — 4 clearances
