Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Entamoeba Histolytica and Related Species Antigen for ID, HA, and CEP Tests is a microbiological reagent used in serological diagnostic assays, including immunodiffusion (ID), hemagglutination (HA), and counterelectrophoresis (CEP), to detect antibodies against Entamoeba histolytica and related amoebic species in patient serum for the diagnosis of amoebiasis. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KHW, regulated under 21 CFR 866.3220, within the Microbiology medical specialty.
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Basic Information
- Product Code
- KHW
- Device Class
- FDA class 2
- Regulation Number
- 866.3220
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K170728 | E. HISTOLYTICA QUIK CHEK | Jun 07, 2017 | Substantially Equivalent | Techlab, Inc. |
| K994101 | E. HISTOLYTICA II | Dec 21, 1999 | Substantially Equivalent | Techlab, Inc. |
| K955895 | E. HISTOLYTICA TEST | Aug 30, 1996 | Substantially Equivalent | Techlab, Inc. |
| K954996 | TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM | Aug 08, 1996 | Substantially Equivalent | Trend Scientific, Inc. |
| K944791 | ENTAMOEBA TEST | Mar 09, 1995 | Substantially Equivalent | Techlab, Inc. |
| K900604 | DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA | Jul 26, 1990 | Substantially Equivalent | Biovir Laboratories, Inc. |
| K890774 | GIARDEIA(TM) | Apr 04, 1989 | Substantially Equivalent | Antibodies, Inc. |
| K890003 | GIARDIA STOOL ANTIGEN TEST KIT | Mar 14, 1989 | Substantially Equivalent | Lmd Laboratories |
| K874849 | PROSPECT/GIARDIA | Jan 05, 1988 | Substantially Equivalent | Alexon Biomedical, Inc. |
| K870318 | AMEBIASIS ELISA TEST KIT | Aug 11, 1987 | Substantially Equivalent | Lmd Laboratories |
| K863811 | AMEBIASIS MICROASSAY | Oct 09, 1986 | Substantially Equivalent | Diamedix Corp. |
| K862473 | PDQ AMEBIASIS | Aug 01, 1986 | Substantially Equivalent | Diamedix Corp. |
| K854230 | MEBIASIS AGAR GEL DIFFUSION KIT | Nov 12, 1985 | Substantially Equivalent | Lmd Laboratories |
| K854017 | ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) | Oct 22, 1985 | Substantially Equivalent | Lmd Laboratories |
| K853448 | HILLCREST AMEBIASIS IHA TEST | Aug 28, 1985 | Substantially Equivalent | Hillcrest Biologicals |
| K844141 | ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC) | Dec 06, 1984 | Substantially Equivalent | Lmd Laboratories |
| K831133 | AMEBIASIS BIO-ENZABEAD SCREEN KIT | Jun 08, 1983 | Substantially Equivalent | Bionetic Laboratory Products |
| K810046 | CORDIA A | Feb 25, 1981 | Substantially Equivalent | Cordis Corp. |
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.