KHW · Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Microbiology · 21 CFR 866.3220 · Class 2
Overview
| Product Code | KHW |
|---|---|
| Device Name | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
| Regulation | 21 CFR 866.3220 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Entamoeba histolytica serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Entamoeba histolytica in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Entamoeba histolytica directly from clinical specimens. The identification aids in the diagnosis of amebiasis caused by the microscopic protozoan parasite Entamoeba histolytica and provides epidemiological information on diseases caused by this parasite. The parasite may invade the skin, liver, intestines, lungs, and diaphragm, causing disease conditions such as indolent ulcers, an amebic hepatitis, amebic dysentery, and pulmonary lesions.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K170728 | E. HISTOLYTICA QUIK CHEK | Techlab, Inc. | Jun 7, 2017 | SESE |
| K994101 | E. HISTOLYTICA II | Techlab, Inc. | Dec 21, 1999 | SESE |
| K955895 | E. HISTOLYTICA TEST | Techlab, Inc. | Aug 30, 1996 | SESE |
| K954996 | TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM | Trend Scientific, Inc. | Aug 8, 1996 | SESE |
| K944791 | ENTAMOEBA TEST | Techlab, Inc. | Mar 9, 1995 | SESE |
| K900604 | DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA | Biovir Laboratories, Inc. | Jul 26, 1990 | SESE |
| K890774 | GIARDEIA(TM) | Antibodies, Inc. | Apr 4, 1989 | SESE |
| K890003 | GIARDIA STOOL ANTIGEN TEST KIT | Lmd Laboratories | Mar 14, 1989 | SESE |
| K874849 | PROSPECT/GIARDIA | Alexon Biomedical, Inc. | Jan 5, 1988 | SESE |
| K870318 | AMEBIASIS ELISA TEST KIT | Lmd Laboratories | Aug 11, 1987 | SESE |
| K863811 | AMEBIASIS MICROASSAY | Diamedix Corp. | Oct 9, 1986 | SESE |
| K862473 | PDQ AMEBIASIS | Diamedix Corp. | Aug 1, 1986 | SESE |
| K854230 | MEBIASIS AGAR GEL DIFFUSION KIT | Lmd Laboratories | Nov 12, 1985 | SESE |
| K854017 | ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) | Lmd Laboratories | Oct 22, 1985 | SESE |
| K853448 | HILLCREST AMEBIASIS IHA TEST | Hillcrest Biologicals | Aug 28, 1985 | SESE |
| K844141 | ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC) | Lmd Laboratories | Dec 6, 1984 | SESE |
| K831133 | AMEBIASIS BIO-ENZABEAD SCREEN KIT | Bionetic Laboratory Products | Jun 8, 1983 | SESE |
| K810046 | CORDIA A | Cordis Corp. | Feb 25, 1981 | SESE |
Top Applicants
- Lmd Laboratories — 5 clearances
- Techlab, Inc. — 4 clearances
- Diamedix Corp. — 2 clearances
- Alexon Biomedical, Inc. — 1 clearance
- Antibodies, Inc. — 1 clearance
