GOD · Antigens, Cf (Including Cf Control), Adenovirus 1-33
Microbiology · 21 CFR 866.3020 · Class 1
Overview
| Product Code | GOD |
|---|---|
| Device Name | Antigens, Cf (Including Cf Control), 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.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K110722 | RPS ADENO DETECTOR PLUS | Rapid Pathogen Screening, Inc. | May 17, 2011 | SESE |
| K052092 | RPS ADENO DETECTOR | Rapid Pathogen Screening | Nov 22, 2005 | SESE |
| K990630 | SAS ADENO TEST | Sa Scientific, Inc. | Aug 19, 1999 | SESE |
| K972406 | ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM | Immunoprobe, Inc. | Dec 22, 1997 | SESE |
| K881894 | ADENOCLONE(R)-TYPE 40/41 EIA DIAGNOSTIC TEST (48) | Cambridge Bioscience Corp. | Jul 8, 1988 | SESE |
| K873312 | ADENOCLONE(TM)-IFA, ADENOVIRUS ANTIGEN TEST | Cambridge Bioscience Corp. | Feb 24, 1988 | SESE |
| K873082 | ADENOCLONE(TM)-EIA ADENOVIRUS ANTIGEN TEST | Cambridge Bioscience Corp. | Feb 24, 1988 | SESE |
| K871229 | ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL | Microscan Div. Baxter Healthcare Corp. | Jun 26, 1987 | SESE |
| K864645 | ADENOLEX (R) LATEX AGGLUTINATION TEST | Orion Diagnostica, Inc. | Jun 4, 1987 | SESE |
| K843649 | ADENOVIRUS | Institute Virion , Ltd. | Sep 26, 1985 | SESE |
| K802929 | ADENO VIRUS & CONTROLS | Orion Diagnostica, Inc. | Dec 31, 1980 | SESE |
Top Applicants
- Cambridge Bioscience Corp. — 3 clearances
- Orion Diagnostica, Inc. — 2 clearances
- Immunoprobe, Inc. — 1 clearance
- Institute Virion , Ltd. — 1 clearance
- Microscan Div. Baxter Healthcare Corp. — 1 clearance
