MHJ · Cryptosporidium Spp.
Microbiology · 21 CFR 866.3220 · Class 2
Overview
| Product Code | MHJ |
|---|---|
| Device Name | Cryptosporidium 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 (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K171078 | TRI-COMBO PARASITE SCREEN | Techlab, Inc. | Jul 10, 2017 | SESE |
| K121565 | UNI-GOLD CRYPTOSPORIDIUM | Trinity Biotech | Feb 8, 2013 | SESE |
| K051929 | GIARDIA/CRYPTOSPORIDIUM CHEK | Techlab, Inc. | Nov 17, 2005 | SESE |
| K052932 | CRYPTOSPORIDIUM II | Techlab, Inc. | Nov 4, 2005 | SESE |
| K031965 | XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 | Remel, Inc. | Nov 14, 2003 | SESE |
| K031059 | IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96 | Ivd Research, Inc. | Jul 10, 2003 | SESE |
| K982764 | PREMIER CRYPTOSPORIDIUM | Meridian Diagnostics, Inc. | Dec 3, 1998 | SESE |
| K982709 | MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY | Alexon - Trend, Inc. | Sep 3, 1998 | SESE |
| K980354 | CRYPTOSPORIDIUM TEST | Techlab, Inc. | May 18, 1998 | SESE |
| K955852 | CRYPTO-CEL IF TEST | Techlab, Inc. | Aug 5, 1996 | SESE |
| K955755 | TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS | Trend Scientific, Inc. | Jul 11, 1996 | SESE |
| K955345 | LMD CRYPTOSPORIDIUM ANTIGEN DETECTION | Lmd Laboratories | Jun 7, 1996 | SESE |
| K936191 | PROSPECT CRYPTOSPORIDIUM RAPID ASSAY | Alexon Biomedical, Inc. | Nov 17, 1994 | SESE |
| K912242 | PROSPECT(TM/CRYPTOSPORIDIUM | Alexon, Inc. | Mar 23, 1992 | SESE |
| K905598 | CRYPTOSPORIDIUM ANTIGEN DETECTION | Lmd Laboratories | Sep 5, 1991 | SESE |
Top Applicants
- Techlab, Inc. — 5 clearances
- Lmd Laboratories — 2 clearances
- Alexon - Trend, Inc. — 1 clearance
- Alexon Biomedical, Inc. — 1 clearance
- Alexon, Inc. — 1 clearance
