LKI · Antisera, Fluorescent, Chlamydia Spp.
Microbiology · 21 CFR 866.3120 · Class 1
Overview
| Product Code | LKI |
|---|---|
| Device Name | Antisera, Fluorescent, Chlamydia Spp. |
| 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K914953 | IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY | Stellar Bio Systems, Inc. | Feb 19, 1992 | SESE |
| K905531 | LUPUS(LE)-LATEX TEST | Immco Diagnostics, Inc. | Jan 25, 1991 | SESE |
| K894625 | CHLAMYDIA (LGV-1) | Bion Ent., Ltd. | Aug 15, 1989 | SESE |
| K883776 | BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE | Btc Corp. | Feb 3, 1989 | SESE |
| K854615 | MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES | Serono Diagnostics, Inc. | Jan 28, 1986 | SESE |
| K830342 | CULUTURE SET CHLAMYDIA ISOLATION AND | Immulok, Inc. | May 4, 1983 | SESE |
Top Applicants
- Bion Ent., Ltd. — 1 clearance
- Btc Corp. — 1 clearance
- Immco Diagnostics, Inc. — 1 clearance
- Immulok, Inc. — 1 clearance
- Serono Diagnostics, Inc. — 1 clearance
