PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT
Device Facts
| Record ID | K884193 |
|---|---|
| Device Name | PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT |
| Applicant | Baxter Diagnostics, Inc. |
| Product Code | GQS · Microbiology |
| Decision Date | Nov 22, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3400 |
| Device Class | Class 1 |
Regulatory Classification
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.
