LJP · Antiserum, Fluorescent, Chlamydia Trachomatis
Microbiology · 21 CFR 866.3120 · Class 1
Overview
| Product Code | LJP |
|---|---|
| Device Name | Antiserum, Fluorescent, Chlamydia Trachomatis |
| 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 (20 of 35)
Showing 20 most recent of 35 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K063675 | DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT | Diagnostic Hybrids, Inc. | Sep 24, 2007 | SESE |
| K941714 | CHLAMYDIA TRACHOMATIS ANTIGEN TEST | Neogenex | Jul 18, 1994 | SESE |
| K901243 | CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST | Cel Labs Pty, Ltd. | May 21, 1990 | SESE |
| K900870 | PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST | Diagnostic Products Corp. | Apr 16, 1990 | SESE |
| K895839 | PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1 | Diagnostic Products Corp. | Feb 1, 1990 | SESE |
| K883352 | FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI | Whittaker Bioproducts, Inc. | Oct 6, 1988 | SESE |
| K881500 | ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST | Ortho Diagnostic Systems, Inc. | Apr 27, 1988 | SESE |
| K880031 | PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS | Kallestad Diag, A Div. of Erbamont, Inc. | Mar 17, 1988 | SESE |
| K872744 | MODIFIED CHLAMYSET ANTIGEN | Orion Corp. | Sep 22, 1987 | SESE |
| K872903 | MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT. | Syva Co. | Aug 6, 1987 | SESE |
| K870946 | MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST | Serono Diagnostics, Inc. | Apr 29, 1987 | SESE |
| K864128 | CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT | Diagnostic Technology, Inc. | Apr 29, 1987 | SESE |
| K871278 | MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT | California Integrated Diagnostics, Inc. | Apr 8, 1987 | SESE |
| K864662 | CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS | American Micro Scan | Mar 25, 1987 | SESE |
| K864539 | MODIFIED IMAGEN(TM) CHLAMYDIA TEST | Boots-Celltech Diagnostics, Inc. | Mar 12, 1987 | SESE |
| K864888 | MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST | Syva Co. | Feb 25, 1987 | SESE |
| K864663 | PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM | Kallestad Diag, A Div. of Erbamont, Inc. | Feb 2, 1987 | SESE |
| K864389 | CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST | American Micro Scan | Dec 4, 1986 | SESE |
| K863681 | PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM | Kallestad Laboratories, Inc. | Dec 3, 1986 | SESE |
| K862354 | MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT | Synbiotics Corp. | Sep 29, 1986 | SESE |
Top Applicants
- Syva Co. — 7 clearances
- American Micro Scan — 2 clearances
- Amico Lab, Inc. — 2 clearances
- Diagnostic Products Corp. — 2 clearances
- Difco Laboratories, Inc. — 2 clearances
