GQP · Antisera, Neutralization, Parainfluenza Virus 1-4
Microbiology · 21 CFR 866.3400 · Class 1
Overview
| Product Code | GQP |
|---|---|
| Device Name | Antisera, Neutralization, Parainfluenza Virus 1-4 |
| Regulation | 21 CFR 866.3400 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Parainfluenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to parainfluenza virus in serum. The identification aids in the diagnosis of parainfluenza virus infections and provides epidemiological information on diseases caused by these viruses. Parainfluenza viruses cause a variety of respiratory illnesses ranging from the common cold to pneumonia.
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 the limitations in § 866.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K981226 | IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 | Dako Diagnostics , Ltd. | Sep 28, 1998 | SESE |
| K933575 | VIRASTAT(R) FITC-LABEL ANTI-PARAINFLU 1,2&3 MONO ANT | Symex Corp. | Nov 28, 1994 | SESE |
Top Applicants
- Dako Diagnostics , Ltd. — 1 clearance
- Symex Corp. — 1 clearance
