GNG · Antigens, Cf (Including Cf Control), Coxsackievirus A 1-24, B 1-6
Microbiology · 21 CFR 866.3145 · Class 1
Overview
| Product Code | GNG |
|---|---|
| Device Name | Antigens, Cf (Including Cf Control), 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K921618 | COXSACKIE VIRUS B1-B6 CF ANTIGENS | Virion (U.S.), Inc. | Jun 29, 1992 | SESE |
| K850003 | COXSACKIE B SERIES CF ANTIGENS | Hillcrest Biologicals | Mar 5, 1985 | SESE |
Top Applicants
- Hillcrest Biologicals — 1 clearance
- Virion (U.S.), Inc. — 1 clearance
