GPW · Antigen, Cf, Psittacosis (Chlamydia Group)
Microbiology · 21 CFR 866.3120 · Class 1
Overview
| Product Code | GPW |
|---|---|
| Device Name | Antigen, Cf, Psittacosis (Chlamydia Group) |
| Regulation | 21 CFR 866.3120 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Chlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).
Classification Rationale
Class I (general controls).
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K872700 | YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGEN | Sita, Inc. | Oct 15, 1987 | SESE |
| K843654 | CHLAMYDIA | Institute Virion , Ltd. | Aug 8, 1985 | SESE |
| K844868 | CHLAMYDIA GROUP CF ANTIGEN | Hillcrest Biologicals | Mar 5, 1985 | SESE |
| K811570 | ANTIBODY TO CHLAMYDIA TRACHOMATIS | Electro-Nucleonics Laboratories, Inc. | Jul 23, 1981 | SESE |
Top Applicants
- Electro-Nucleonics Laboratories, Inc. — 1 clearance
- Hillcrest Biologicals — 1 clearance
- Institute Virion , Ltd. — 1 clearance
- Sita, Inc. — 1 clearance
