Product code LJC
- Device name
- Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
- 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 |
|---|---|---|---|
| K032330 | CT OIA | Thermo Biostar, Inc. | 2004-03-02 |
| K033865 | IDEIA PCE CHLAMYDIA | Dakocytomation, Ltd. | 2004-01-21 |
| K033079 | CHLAMYDIA IGG ELISA TEST SYSTEM | Trinity Biotech USA | 2003-11-26 |
| K982210 | MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA | Dade Behring, Inc. | 1998-07-09 |
| K962558 | CHLAMYDIA IGG ELISA TEST SYSTEM | Armkel, LLC | 1997-02-24 |
| K960850 | ACCESS CHLAMYDIA ASSAY | Bio-Rad Laboratories, Inc. | 1997-02-04 |
| K955627 | VIDAS CHLAMYDIA BLOCKING ASSAY | Biomerieux Vitek, Inc. | 1996-10-07 |
| K936054 | IMX SELECT CHLAMYDIA | Abbott Laboratories | 1996-05-30 |
| K940564 | IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION | Dako Diagnostics , Ltd. | 1996-01-11 |
| K951010 | CHLAMYDIA OIA | Biostar, Inc. | 1995-10-07 |
| K946276 | QUICKVUE(R) CHLAMYDIA TEST | Quidel Corp. | 1995-05-19 |
| K935807 | ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY | Bio-Rad Laboratories, Inc. | 1995-05-19 |
| K935393 | CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY | Bio-Rad Laboratories, Inc. | 1994-09-20 |
| K926090 | SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT | Syva Co. | 1993-09-30 |
| K921747 | MICRO TRAK XL SYSTEM | Syva Co. | 1992-10-01 |
| K921462 | MICROTRAK(R) II CHLAMYDIA EIA ASSAY | Syva Co. | 1992-09-25 |
| K920503 | SYVA MICROTRAK CHLAMYDIA EIA | Syva Co. | 1992-09-25 |
| K921321 | ORTHO CHLAMYDIA ANTIGEN ELISA TEST | Ortho Diagnostic Systems, Inc. | 1992-08-11 |
| K914327 | SEROELISA(TM) CHLAMYDIA IGA TEST KIT | Savyon Diagnostics , Ltd. | 1992-06-09 |
| K915281 | SEROLISA CHLAMYDIA IGG TEST KIT | Savyon Diagnostics , Ltd. | 1992-03-23 |
| K915884 | VIDAS CHLAMYDIA ASSAY, MODIFICATION | Vitek Systems, Inc. | 1992-03-04 |
| K912680 | ANTIGENZ CHLAMYDIA | Baxter Diagnostics, Inc. | 1991-07-22 |
| K905787 | VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST | Vitek Systems, Inc. | 1991-04-29 |
| K904189 | CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-03-27 |
| K910668 | ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION | Ortho Diagnostic Systems, Inc. | 1991-03-19 |
| K905179 | SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION | Syva Co. | 1991-03-12 |
| K904725 | CHLAMYDIA SYSTEM SOFTWARE (CSS) | Kallestad Diag, A Div. of Erbamont, Inc. | 1991-01-14 |
| K903132 | ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF | Ortho Diagnostic Systems, Inc. | 1990-12-21 |
| K903765 | QUIDEL CHLAMYDIA POSITIVE CONTROL | Quidel Corp. | 1990-10-02 |
| K903758 | SYVA MICROTRAK EIA ACCESSORY REAGENTS | Syva Co. | 1990-09-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07290001913147 | SeroELISA Chlamydia IgG | SAVYON DIAGNOSTICS LTD | 2025-05-29 |
| 07290001913161 | SeroELISA Chlamydia IgA | SAVYON DIAGNOSTICS LTD | 2025-05-29 |
| 30014613200062 | QuickVue | QUIDEL CORPORATION | 2018-11-10 |
| 05391516743952 | Trinity Biotech | CLARK LABORATORIES, INC. | 2017-05-07 |