Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Microbiology · 21 CFR 866.3220
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
16 firms currently registered for this product code
Bordier Affinity Products Sa
Crissier Vaud, CH
Aceso Laboratories Inc.
Chino, CA, US
Gold Standard Diagnostics Frankfurt Gmbh
Dietzenbach Hesse, DE
Immunocentrix Corporation
Canoga Park, CA, US
Techlab, Inc.
Radford, VA, US
Gold Standard Diagnostics, Llc
Davis, CA, US
Techlab, Inc.
BLACKSBURG, VA, US
Acro Biotech Inc.
Montclair, CA, US
Eiger Diagnostics, Inc.
Las Vegas, NV, US
New Life Diagnostics Inc.
Carlsbad, CA, US
Drg International, Inc.
Springfield, NJ, US
Drg Instruments Gmbh
MARBURG Hesse, DE
510(k) clearances
18 clearances for this product code
- Techlab, Inc.Jun 7, 2017
K170728 · E. HISTOLYTICA QUIK CHEK
- Techlab, Inc.Dec 21, 1999
K994101 · E. HISTOLYTICA II
- Techlab, Inc.Aug 30, 1996
K955895 · E. HISTOLYTICA TEST
- Trend Scientific, Inc.Aug 8, 1996
K954996 · TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM
- Techlab, Inc.Mar 9, 1995
K944791 · ENTAMOEBA TEST
- Biovir Laboratories, Inc.Jul 26, 1990
K900604 · DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIA
- Antibodies, Inc.Apr 4, 1989
K890774 · GIARDEIA(TM)
- Lmd LaboratoriesMar 14, 1989
K890003 · GIARDIA STOOL ANTIGEN TEST KIT