Product code LJP
- Device name
- Antiserum, Fluorescent, Chlamydia Trachomatis
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3120
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K063675 | DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT | Diagnostic Hybrids, Inc. | 2007-09-24 |
| K941714 | CHLAMYDIA TRACHOMATIS ANTIGEN TEST | Neogenex | 1994-07-18 |
| K901243 | CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST | Cel Labs Pty, Ltd. | 1990-05-21 |
| K900870 | PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST | Diagnostic Products Corp. | 1990-04-16 |
| K895839 | PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1 | Diagnostic Products Corp. | 1990-02-01 |
| K883352 | FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI | Whittaker Bioproducts, Inc. | 1988-10-06 |
| K881500 | ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST | Ortho Diagnostic Systems, Inc. | 1988-04-27 |
| K880031 | PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-03-17 |
| K872744 | MODIFIED CHLAMYSET ANTIGEN | Orion Corp. | 1987-09-22 |
| K872903 | MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT. | Syva Co. | 1987-08-06 |
| K870946 | MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST | Serono Diagnostics, Inc. | 1987-04-29 |
| K864128 | CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT | Diagnostic Technology, Inc. | 1987-04-29 |
| K871278 | MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT | California Integrated Diagnostics, Inc. | 1987-04-08 |
| K864662 | CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS | American Micro Scan | 1987-03-25 |
| K864539 | MODIFIED IMAGEN(TM) CHLAMYDIA TEST | Boots-Celltech Diagnostics, Inc. | 1987-03-12 |
| K864888 | MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST | Syva Co. | 1987-02-25 |
| K864663 | PATHFINDER CHLAMYDIA CULTURE CONFIRMATION SYSTEM | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-02-02 |
| K864389 | CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST | American Micro Scan | 1986-12-04 |
| K863681 | PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM | Kallestad Laboratories, Inc. | 1986-12-03 |
| K862354 | MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT | Synbiotics Corp. | 1986-09-29 |
| K862320 | DIFCO CHLAMYDIA DIRECT DETECTION SYSTEM | Difco Laboratories, Inc. | 1986-08-19 |
| K853401 | CHLAMYSET ANTIGEN | Orion Corp. | 1986-04-28 |
| K860179 | CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT | Difco Laboratories, Inc. | 1986-03-10 |
| K853738 | ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST | Ortho Diagnostic Systems, Inc. | 1985-12-06 |
| K852779 | MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST | Syva Co. | 1985-09-16 |
| K851033 | SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT | Syncor Intl. Corp. | 1985-06-21 |
| K850158 | CHLAMYDIA FLUORO-KIT 1680 | Clinical Sciences, Inc. | 1985-03-21 |
| K844582 | SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST | Syncor Intl. Corp. | 1985-01-16 |
| K842658 | ANTI-CHLAMYDIA TRACHOMATIS KIT | Amico Lab, Inc. | 1984-10-01 |
| K842525 | AMIZYME-C TRACHOMATIS TEST KIT | Amico Lab, Inc. | 1984-10-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05032384503032 | IMAGEN CHLAMYDIA POSITIVE CONTROL SLIDE | OXOID LIMITED | 2024-07-03 |
| 05032384502943 | IMAGEN Chlamydia | OXOID LIMITED | 2024-06-19 |
| G5229030001 | Chlamydia trachomatis / C. trach IgG IFA 96 Test | Hemagen Diagnostics, Inc. | 2023-10-05 |
| G5229030011 | Chlamydia trachomatis / C. trach IgG IFA Slide Only Kit | Hemagen Diagnostics, Inc. | 2023-10-05 |
| 00847865001410 | Pathfinder | Bio-RAD Laboratories, Inc. | 2023-01-04 |
| 00847865001427 | Pathfinder | Bio-RAD Laboratories, Inc. | 2023-01-04 |
| 00847865001434 | Pathfinder | Bio-RAD Laboratories, Inc. | 2023-01-04 |
| 00847865001441 | Pathfinder | Bio-RAD Laboratories, Inc. | 2023-01-04 |
| 00847865012775 | Pathfinder | Bio-RAD Laboratories, Inc. | 2023-01-04 |
| 05056080501901 | PathoDx Chlamydia trachomatis Control Slide | REMEL EUROPE LIMITED | 2021-07-21 |
| 05056080501918 | PathoDx Chlamydia Culture Confirmation | REMEL EUROPE LIMITED | 2021-07-21 |
| 05056080501925 | PathoDx Chlamydia trachomatis Direct Specimen | REMEL EUROPE LIMITED | 2021-07-21 |
| 30014613330547 | D3 | DIAGNOSTIC HYBRIDS, INC. | 2018-08-30 |
| 30014613330554 | D3 | DIAGNOSTIC HYBRIDS, INC. | 2018-07-22 |