LKH · Antisera, Immunoperoxidase, Chlamydia Spp.
Microbiology · 21 CFR 866.3120 · Class 1
Overview
| Product Code | LKH |
|---|---|
| Device Name | Antisera, Immunoperoxidase, Chlamydia Spp. |
| 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K910644 | IPAZYME (TM) CHLAMYDIA IGG-IGA | Savyon Diagnostics , Ltd. | Mar 19, 1991 | SESE |
| K901975 | IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) | Savyon Diagnostics , Ltd. | Mar 8, 1991 | SESE |
| K882674 | IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT | Icn Immunobiologicals | Aug 15, 1989 | SESE |
| K893669 | CELLMATICS SHLAMYDIA DETECTION SYSTEM | Difco Laboratories, Inc. | Jun 23, 1989 | SESE |
| K852869 | SELECTICULT-CHLAMYDIA | Scott Laboratories, Inc. | Sep 19, 1985 | SESE |
| K842151 | CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT | Bartels Immunodiagnostic Supplies, Inc. | Jul 20, 1984 | SESE |
| K830688 | COMBION SKIN TEST | Nicholas H. Maganias | Mar 31, 1983 | SESE |
| K820390 | HISTOSET IMMUNOPEROXIDASE TISSURE KIT | Immulok, Inc. | Apr 14, 1982 | SESE |
Top Applicants
- Savyon Diagnostics , Ltd. — 2 clearances
- Bartels Immunodiagnostic Supplies, Inc. — 1 clearance
- Difco Laboratories, Inc. — 1 clearance
- Icn Immunobiologicals — 1 clearance
- Immulok, Inc. — 1 clearance
