Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
FDA product code LJC · Class I (low risk) · 21 CFR 866.3120 · Microbiology
67510(k) clearances
0PMA approvals
4recalls
Manufacturers
- Abbott Laboratories 10
- Syva Co. 7
- Ortho Diagnostic Systems, Inc. 4
- Kallestad Diag, A Div. of Erbamont, Inc. 4
- Eastman Kodak Company 4
- Boots-Celltech Diagnostics, Inc. 3
- Quidel Corp. 3
- Bio-Rad Laboratories, Inc. 3
- Ciba Corning Diagnostics Corp. 3
- Vitek Systems, Inc. 2
- Savyon Diagnostics , Ltd. 2
- Fairleigh Dickinson Laboratories, Inc. 2
- Pharmacia, Inc. 1
- Orion Corp. 1
- Seragen Diagnostics, Inc. 1
- Thermo Biostar, Inc. 1
- Orgenics, Ltd. 1
- Intercare Diagnostics, Inc. 1
- Isolab, Inc. 1
- Apple Diagnostic Products 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032330 | CT OiaLJC · Traditional | Thermo Biostar, Inc. | 03/02/2004SE |
| K033865 | Ideia Pce ChlamydiaLJC · Special | Dakocytomation, Ltd. | 01/21/2004SE |
| K033079 | Chlamydia Igg Elisa Test SystemLJC · Traditional | Trinity Biotech USA | 11/26/2003SE |
| K982210 | Modification of Syva Microtrak II Chlamydia EiaLJC · Special | Dade Behring, Inc. | 07/09/1998SE |
| K962558 | Chlamydia Igg Elisa Test SystemLJC · Traditional | Armkel, LLC | 02/24/1997SE |
| K960850 | Access Chlamydia AssayLJC · Traditional | Bio-Rad Laboratories, Inc. | 02/04/1997SE |
| K955627 | Vidas Chlamydia Blocking AssayLJC · Traditional | Biomerieux Vitek, Inc. | 10/07/1996SE |
| K936054 | Imx Select ChlamydiaLJC · Traditional | Abbott Laboratories | 05/30/1996SE |
| K940564 | Ideia(Tm) Chlamydia Blocking Reagents, ModificationLJC · Traditional | Dako Diagnostics , Ltd. | 01/11/1996SE |
| K951010 | Chlamydia OiaLJC · Traditional | Biostar, Inc. | 10/07/1995SE |
| K946276 | Quickvue(R) Chlamydia TestLJC · Traditional | Quidel Corp. | 05/19/1995SE |
| K935807 | Access(R) Chlamydia Eia and Blocking AssayLJC · Traditional | Bio-Rad Laboratories, Inc. | 05/19/1995SE |
| K935393 | Chlamydia Microplate Eia, Chlamydia Microplae Eia Blocking AssayLJC · Traditional | Bio-Rad Laboratories, Inc. | 09/20/1994SE |
| K926090 | Syva Microtrak(R) II Chlamydia Eia Block ReagentLJC · Traditional | Syva Co. | 09/30/1993SE |
| K921747 | Micro Trak XL SystemLJC · Traditional | Syva Co. | 10/01/1992SE |
| K921462 | Microtrak(R) II Chlamydia Eia AssayLJC · Traditional | Syva Co. | 09/25/1992SE |
| K920503 | Syva Microtrak Chlamydia EiaLJC · Traditional | Syva Co. | 09/25/1992SE |
| K921321 | Ortho Chlamydia Antigen Elisa TestLJC · Traditional | Ortho Diagnostic Systems, Inc. | 08/11/1992SE |
| K914327 | Seroelisa(Tm) Chlamydia Iga Test KitLJC · Traditional | Savyon Diagnostics , Ltd. | 06/09/1992SE |
| K915281 | Serolisa Chlamydia Igg Test KitLJC · Traditional | Savyon Diagnostics , Ltd. | 03/23/1992SE |
| K915884 | Vidas Chlamydia Assay, ModificationLJC · Traditional | Vitek Systems, Inc. | 03/04/1992SE |
| K912680 | Antigenz ChlamydiaLJC · Traditional | Baxter Diagnostics, Inc. | 07/22/1991SE |
| K905787 | Vidas Chlamydia Assay Vitek Immundiag Assay SystLJC · Traditional | Vitek Systems, Inc. | 04/29/1991SE |
| K904189 | Ciba Corning Magic Lite Chlamydia ImmunoassayLJC · Traditional | Ciba Corning Diagnostics Corp. | 03/27/1991SE |
| K910668 | Ortho* Chlamydia Antigen Elisa Test/ModificationLJC · Traditional | Ortho Diagnostic Systems, Inc. | 03/19/1991SE |
| K905179 | Syva Microtrak Chlamlydia Eia, ModificationLJC · Traditional | Syva Co. | 03/12/1991SE |
| K904725 | Chlamydia System Software (CSS)LJC · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 01/14/1991SE |
| K903132 | Ortho Chlamydia Antigen Elisa/Elisa Cult Extra BufLJC · Traditional | Ortho Diagnostic Systems, Inc. | 12/21/1990SE |
| K903765 | Quidel Chlamydia Positive ControlLJC · Traditional | Quidel Corp. | 10/02/1990SE |
| K903758 | Syva Microtrak Eia Accessory ReagentsLJC · Traditional | Syva Co. | 09/12/1990SE |
| K901972 | Add'L Claimed Intended Use for Ideia(Tm) ChlamydiaLJC · Traditional | Novo Nordisk Diagnostics, Ltd. | 09/05/1990SE |
| K902270 | Ciba Corning Magic Lite Chlamydia ImmunoassayLJC · Traditional | Ciba Corning Diagnostics Corp. | 07/31/1990SE |
| K901660 | Quidel Chlamydia TestLJC · Traditional | Quidel Corp. | 07/27/1990SE |
| K902253 | Pathfinder(Tm) Chlamydia Microplate KitLJC · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 07/26/1990SE |
| K901934 | Kodak Surecell(Tm) Chlamydia Control Fluid SetLJC · Traditional | Eastman Kodak Company | 06/20/1990SE |
| K900973 | Visuwell(R) ChlamydiaLJC · Traditional | Adi Diagnostics, Inc. | 05/15/1990SE |
| K900543 | Chlamydiazyme Diagnostic KitLJC · Traditional | Abbott Laboratories | 05/03/1990SE |
| K895468 | Orgenics Immunocomb(Tm) Chlamydia Trachomatis IggLJC · Traditional | Orgenics, Ltd. | 03/13/1990SE |
| K900402 | Add'L Uses for the Kodak Surecell Chlamydia KitLJC · Traditional | Eastman Kodak Company | 03/08/1990SE |
| K896032 | Modified Elisa for ChlamydiaLJC · Traditional | Fairleigh Dickinson Laboratories, Inc. | 01/29/1990SE |
| K895280 | Clearview ChlamydiaLJC · Traditional | Unipath , Ltd. | 01/29/1990SE |
| K895505 | Kodak Surecell Chlamydia Test Kit (Add'L Uses)LJC · Traditional | Eastman Kodak Company | 01/02/1990SE |
| K895122 | Ciba Corning Magic Lite Chlamydia ImmunoassayLJC · Traditional | Ciba Corning Diagnostics Corp. | 10/30/1989SE |
| K893676 | Abbott Testpack ChlamydiaLJC · Traditional | Abbott Laboratories | 07/25/1989SE |
| K892371 | Chlamydiazyme Blocking ReagentLJC · Traditional | Abbott Laboratories | 06/02/1989SE |
| K890196 | Microtrak Chlamydia EiaLJC · Traditional | Syva Co. | 03/22/1989SE |
| K885006 | Chlamydiazyme/Commander InstrumentationLJC · Traditional | Abbott Laboratories | 12/16/1988SE |
| K880799 | Modified Ideia Chlamydia TestLJC · Traditional | Boots-Celltech Diagnostics, Inc. | 12/08/1988SE |
| K884517 | Pathfinder(Tm) Chlamydia Eia Detect Kit/ModifiedLJC · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 11/30/1988SE |
| K882923 | Kodak Surecell Chlamydia Test KitLJC · Traditional | Eastman Kodak Company | 11/10/1988SE |
| K883266 | FDL Elisa for ChlamydiaLJC · Traditional | Fairleigh Dickinson Laboratories, Inc. | 10/25/1988SE |
| K882676 | Pharmacia Chlamydia EiaLJC · Traditional | Pharmacia, Inc. | 08/29/1988SE |
| K880783 | Abbott Testpack ChlamydiaLJC · Traditional | Abbott Laboratories | 07/25/1988SE |
| K882535 | Abbott Testpack(Tm) Chlamydia Positive ControlLJC · Traditional | Abbott Laboratories | 07/14/1988SE |
| K880469 | Chlamydiazyme(Tm)LJC · Traditional | Abbott Laboratories | 05/23/1988SE |
| K880824 | Pathfinder(Tm) Chlamydia Eia Detection KitLJC · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 04/12/1988SE |
| K864457 | Chlamyset Antibody EiaLJC · Traditional | Orion Corp. | 09/11/1987SE |
| K872148 | Vivid Chlamydia(Tm)LJC · Traditional | Seragen Diagnostics, Inc. | 08/19/1987SE |
| K872056 | Modified (Directions for Use) for Ideia(Tm) TestLJC · Traditional | Boots-Celltech Diagnostics, Inc. | 06/15/1987SE |
| K864842 | Chlamydiazyme Diagnostic KitLJC · Traditional | Abbott Laboratories | 04/29/1987SE |
| K863490 | Ortho* Chlamydia Antigen Elisa Test & TransportLJC · Traditional | Ortho Diagnostic Systems, Inc. | 11/05/1986SE |
| K862948 | Chlamydia Tissue Culture Confirmation Test (Eia)LJC · Traditional | Intercare Diagnostics, Inc. | 10/17/1986SE |
| K862638 | Visible-Chlamydia(Tm) Test SystemLJC · Traditional | Isolab, Inc. | 08/26/1986SE |
| K861966 | Modified Ideia Chlamydia TestLJC · Traditional | Boots-Celltech Diagnostics, Inc. | 08/19/1986SE |
| K843120 | Applelisa Chlamydia Trachomatis AntiLJC · Traditional | Apple Diagnostic Products | 09/12/1984SE |
| K831962 | Chlamydiazyme, Enzyme Immunoassay DetecLJC · Traditional | Abbott Laboratories | 10/05/1983SE |
| K821967 | Chlamydelisa Test KitLJC · Traditional | M.A. Bioproducts | 08/03/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0730-2026 Class II | Chlamydia TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-3129-2011 | VIDAS Chlamydia test kits VIDAS Chlamydia is an automated qualitative test for use on…Complaints were received of high rates of false positive results, leading to unnecessary antibiotic therapy… | bioMerieux, Inc. | 07/08/2011Terminated |
| Z-0986-2010 | Chlamydia Pneumoniae IgM ELISA 96 Well Kit, Catalog Number: CP095M The products in…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | Calbiotech Inc | 08/27/2008Terminated |
| Z-0985-2010 | Chlamydia Pneumoniae IgG ELISA 96 Well Kit, Catalog Number: CP083G The products in…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | Calbiotech Inc | 08/27/2008Terminated |