MHI · Giardia Spp.
Microbiology · 21 CFR 866.3220 · Class 2
Overview
| Product Code | MHI |
|---|---|
| Device Name | Giardia 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 (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K120001 | UNIGOLD GIARDIA | Trinity Biotech | Mar 1, 2013 | SESE |
| K103673 | GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK | Techlab Inc., Corporate Research Center | Aug 18, 2011 | SESE |
| K081064 | GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF | Ivd Research, Inc. | Jan 14, 2009 | SESE |
| K031942 | XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 | Remel, Inc. | Nov 18, 2003 | SESE |
| K031834 | XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY | Remel, Inc. | Nov 10, 2003 | SESE |
| K033274 | GIARDIA II | Techlab, Inc. | Nov 4, 2003 | SESE |
| K024113 | IVD CRYPTO/GIARDIA DFA | Ivd Research, Inc. | Mar 5, 2003 | SESE |
| K020583 | IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 | Ivd Research, Inc. | Sep 17, 2002 | SESE |
| K983399 | GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY | Genzyme Diagnostics | Jan 11, 1999 | SESE |
| K982711 | PREMIER GIARDIA | Meridian Diagnostics, Inc. | Nov 25, 1998 | SESE |
| K982245 | TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA | Biosite Incorporated | Oct 6, 1998 | SESE |
| K963135 | GIARDIA CELISA | Techlab, Inc. | Nov 29, 1996 | SESE |
| K955897 | CRYPTO/GIARDIA-CEL IF TEST | Techlab, Inc. | Aug 5, 1996 | SESE |
| K955157 | PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY | Alexon Biomedical, Inc. | Feb 9, 1996 | SESE |
| K952467 | TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT) | Trend Scientific, Inc. | Nov 20, 1995 | SESE |
| K953284 | TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM | Trend Scientific, Inc. | Oct 6, 1995 | SESE |
| K944871 | LMD GIARDIA ANTIGEN DETECTION ASSAY | Lmd Laboratories | Jun 22, 1995 | SESE |
| K942098 | PROSPECT GIARDIA | Alexon, Inc. | Sep 9, 1994 | SESE |
| K931147 | PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION | Alexon, Inc. | May 13, 1993 | SESE |
| K930451 | PROSPEC T GIARDIA MICROTITER ASSAY | Alexon, Inc. | Apr 21, 1993 | SESE |
Top Applicants
- Alexon, Inc. — 8 clearances
- Ivd Research, Inc. — 3 clearances
- Techlab, Inc. — 3 clearances
- Meridian Diagnostics, Inc. — 2 clearances
- Remel, Inc. — 2 clearances
