Antiserum, Fluorescent, Chlamydia Trachomatis
FDA product code LJP · Class I (low risk) · 21 CFR 866.3120 · Microbiology
35510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Syva Co. 7
- Amico Lab, Inc. 2
- Syncor Intl. Corp. 2
- Ortho Diagnostic Systems, Inc. 2
- Difco Laboratories, Inc. 2
- Orion Corp. 2
- Diagnostic Products Corp. 2
- American Micro Scan 2
- Kallestad Diag, A Div. of Erbamont, Inc. 2
- Diagnostic Hybrids, Inc. 1
- Neogenex 1
- Cel Labs Pty, Ltd. 1
- Whittaker Bioproducts, Inc. 1
- Serono Diagnostics, Inc. 1
- Diagnostic Technology, Inc. 1
- California Integrated Diagnostics, Inc. 1
- Boots-Celltech Diagnostics, Inc. 1
- Kallestad Laboratories, Inc. 1
- Synbiotics Corp. 1
- Clinical Sciences, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K063675 | Diagnostic Hybrids' D3 Dfa Chlamydiae Culture Confirmation KitLJP · Traditional | Diagnostic Hybrids, Inc. | 09/24/2007SE |
| K941714 | Chlamydia Trachomatis Antigen TestLJP · Traditional | Neogenex | 07/18/1994SE |
| K901243 | Chlamydia-Cel Immunofluorenscence (If) TestLJP · Traditional | Cel Labs Pty, Ltd. | 05/21/1990SE |
| K900870 | Pathodx Chlamydia Trachomatis Direct Specimen TestLJP · Traditional | Diagnostic Products Corp. | 04/16/1990SE |
| K895839 | Pathodx Chlamydia Culture Confirmation PKCC1LJP · Traditional | Diagnostic Products Corp. | 02/01/1990SE |
| K883352 | Fluorescein Conjugated Anti-Chlamydia Mono AntiLJP · Traditional | Whittaker Bioproducts, Inc. | 10/06/1988SE |
| K881500 | Ortho* Chlamydia Direct Detection (Fa) TestLJP · Traditional | Ortho Diagnostic Systems, Inc. | 04/27/1988SE |
| K880031 | Pathfinder(Tm) Direct Detection Sys C. TrachomatisLJP · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 03/17/1988SE |
| K872744 | Modified Chlamyset AntigenLJP · Traditional | Orion Corp. | 09/22/1987SE |
| K872903 | Microtrak Chlamydia Tracho. Test - Methanol Fixat.LJP · Traditional | Syva Co. | 08/06/1987SE |
| K870946 | Monabrite Chlamydia Trachomatis Dir. Specimen TestLJP · Traditional | Serono Diagnostics, Inc. | 04/29/1987SE |
| K864128 | Chlamydia-Check(Tm) Direct & Culture Confir. KitLJP · Traditional | Diagnostic Technology, Inc. | 04/29/1987SE |
| K871278 | Modified Chlamydia Direct Specimen Test KitLJP · Traditional | California Integrated Diagnostics, Inc. | 04/08/1987SE |
| K864662 | Chlamydiae Fluor. AB Test for Detection in SmearsLJP · Traditional | American Micro Scan | 03/25/1987SE |
| K864539 | Modified Imagen(Tm) Chlamydia TestLJP · Traditional | Boots-Celltech Diagnostics, Inc. | 03/12/1987SE |
| K864888 | Microtrak Chlamydia Trachomatis Direct Speci. TestLJP · Traditional | Syva Co. | 02/25/1987SE |
| K864663 | Pathfinder Chlamydia Culture Confirmation SystemLJP · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 02/02/1987SE |
| K864389 | Chlamydiae Flourescent Monoclonal Antibody TestLJP · Traditional | American Micro Scan | 12/04/1986SE |
| K863681 | Pathfinder(Tm) Direct Antigen Detection SystemLJP · Traditional | Kallestad Laboratories, Inc. | 12/03/1986SE |
| K862354 | Monofluor Chlamydia Trachomatis Dir Spec Test KitLJP · Traditional | Synbiotics Corp. | 09/29/1986SE |
| K862320 | Difco Chlamydia Direct Detection SystemLJP · Traditional | Difco Laboratories, Inc. | 08/19/1986SE |
| K853401 | Chlamyset AntigenLJP · Traditional | Orion Corp. | 04/28/1986SE |
| K860179 | Cellmatics Chlamydia Monoclonal Dfa ReagentLJP · Traditional | Difco Laboratories, Inc. | 03/10/1986SE |
| K853738 | Ortho Chlamydia Direct Detection (Fa) TestLJP · Traditional | Ortho Diagnostic Systems, Inc. | 12/06/1985SE |
| K852779 | Microtrak Chlamydia Trachomatis Dir Specimen TestLJP · Traditional | Syva Co. | 09/16/1985SE |
| K851033 | Syncortech Chlamydia Direct Speciman KitLJP · Traditional | Syncor Intl. Corp. | 06/21/1985SE |
| K850158 | Chlamydia Fluoro-Kit 1680LJP · Traditional | Clinical Sciences, Inc. | 03/21/1985SE |
| K844582 | Syncor Tech Chlamydia Tissue Culture TestLJP · Traditional | Syncor Intl. Corp. | 01/16/1985SE |
| K842658 | Anti-Chlamydia Trachomatis KitLJP · Traditional | Amico Lab, Inc. | 10/01/1984SE |
| K842525 | Amizyme-C Trachomatis Test KitLJP · Traditional | Amico Lab, Inc. | 10/01/1984SE |
| K842623 | Microtrak Chlamydia Trachomatis DirectLJP · Traditional | Syva Co. | 08/02/1984SE |
| K834242 | Adp Ifa Test for Chlamydiae TrachomatisLJP · Traditional | Apple Diagnostic Products | 03/02/1984SE |
| K832078 | Micro Trak Chlamydia Trac Control SlidLJP · Traditional | Syva Co. | 09/29/1983SE |
| K832077 | Micro Trak Chlamydia Trachomatis DirectLJP · Traditional | Syva Co. | 09/29/1983SE |
| K823010 | Micro Trak Chlamydia Trachomatis CultLJP · Traditional | Syva Co. | 12/15/1982SE |