GNY · Antisera, Fluorescent, Adenovirus 1-33
Microbiology · 21 CFR 866.3020 · Class 1
Overview
| Product Code | GNY |
|---|---|
| Device Name | Antisera, Fluorescent, Adenovirus 1-33 |
| Regulation | 21 CFR 866.3020 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).
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.
Cleared Devices (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K922801 | RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY | Light Diagnostics | Jan 6, 1993 | SESE |
| K885310 | MURINE MONOCLONAL ANTI-ADENOVIRUS IGG | Whittaker Bioproducts, Inc. | Feb 16, 1989 | SESE |
| K770811 | ADENOVIRUS GROUP-FA LABELLED PRESERUM | Flow Laboratories, Inc. | May 20, 1977 | SESE |
| K770807 | ADENOVIRUS-GROUP FA LABELLED (8-651 RF) | Flow Laboratories, Inc. | May 20, 1977 | SESE |
Top Applicants
- Flow Laboratories, Inc. — 2 clearances
- Whittaker Bioproducts, Inc. — 1 clearance
- Light Diagnostics — 1 clearance
