LJC · Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Microbiology · 21 CFR 866.3120 · Class 1
Overview
| Product Code | LJC |
|---|---|
| Device Name | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) |
| 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 67)
Showing 20 most recent of 67 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K032330 | CT OIA | Thermo Biostar, Inc. | Mar 2, 2004 | SESE |
| K033865 | IDEIA PCE CHLAMYDIA | Dakocytomation, Ltd. | Jan 21, 2004 | SESE |
| K033079 | CHLAMYDIA IGG ELISA TEST SYSTEM | Trinity Biotech USA | Nov 26, 2003 | SESE |
| K982210 | MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA | Dade Behring, Inc. | Jul 9, 1998 | SESE |
| K962558 | CHLAMYDIA IGG ELISA TEST SYSTEM | Armkel, LLC | Feb 24, 1997 | SESE |
| K960850 | ACCESS CHLAMYDIA ASSAY | Bio-Rad Laboratories, Inc. | Feb 4, 1997 | SESE |
| K955627 | VIDAS CHLAMYDIA BLOCKING ASSAY | Biomerieux Vitek, Inc. | Oct 7, 1996 | SESE |
| K936054 | IMX SELECT CHLAMYDIA | Abbott Laboratories | May 30, 1996 | SESE |
| K940564 | IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION | Dako Diagnostics , Ltd. | Jan 11, 1996 | SESE |
| K951010 | CHLAMYDIA OIA | Biostar, Inc. | Oct 7, 1995 | SESE |
| K946276 | QUICKVUE(R) CHLAMYDIA TEST | Quidel Corp. | May 19, 1995 | SESE |
| K935807 | ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY | Bio-Rad Laboratories, Inc. | May 19, 1995 | SESE |
| K935393 | CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY | Bio-Rad Laboratories, Inc. | Sep 20, 1994 | SESE |
| K926090 | SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT | Syva Co. | Sep 30, 1993 | SESE |
| K921747 | MICRO TRAK XL SYSTEM | Syva Co. | Oct 1, 1992 | SESE |
| K921462 | MICROTRAK(R) II CHLAMYDIA EIA ASSAY | Syva Co. | Sep 25, 1992 | SESE |
| K920503 | SYVA MICROTRAK CHLAMYDIA EIA | Syva Co. | Sep 25, 1992 | SESE |
| K921321 | ORTHO CHLAMYDIA ANTIGEN ELISA TEST | Ortho Diagnostic Systems, Inc. | Aug 11, 1992 | SESE |
| K914327 | SEROELISA(TM) CHLAMYDIA IGA TEST KIT | Savyon Diagnostics , Ltd. | Jun 9, 1992 | SESE |
| K915281 | SEROLISA CHLAMYDIA IGG TEST KIT | Savyon Diagnostics , Ltd. | Mar 23, 1992 | SESE |
Top Applicants
- Abbott Laboratories — 10 clearances
- Syva Co. — 7 clearances
- Ortho Diagnostic Systems, Inc. — 4 clearances
- Kallestad Diag, A Div. of Erbamont, Inc. — 4 clearances
- Eastman Kodak Company — 4 clearances
