Antisera, All Types, Escherichia Coli

FDA product code GNA · Class I (low risk) · 21 CFR 866.3255 · Microbiology

12510(k) clearances
0PMA approvals
1recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K071799Modification to Biostar Oia ShigatoxGNA · Traditional Iverness Medical Professional Diagnostics10/02/2007SE
K031367Duopath Verotoxins Glisa TestGNA · Traditional Emd Chemicals, Inc.01/23/2004SE
K993401Dryspot E.Coli 0157 KitGNA · Traditional Oxoid , Ltd.02/28/2000SE
K981734Vtec-Rpla SeikenGNA · Traditional Denka Seiken'S09/22/1998SE
K962028Wellcolex E-Coli OI57 ZC60GNA · Traditional Murex Diagnostics, Inc.11/01/1996SE
K953362Premier EhecGNA · Traditional Meridian Diagnostics, Inc.11/14/1995SE
K950167Premier EhecGNA · Traditional Meridian Diagnostics, Inc.04/14/1995SE
K933457Rim E.Coli 0157:H7 Latex TestGNA · Traditional Remel Co.04/20/1994SE
K903714E. Coli 0157 Latex TestGNA · Traditional Pro-Lab, Inc.01/24/1991SE
K884026Escherichia Coli 0157 Latex Agglutination Test KitGNA · Traditional Oxoid U.S.A., Inc.02/03/1989SE
K874288Phadebact Etec-Lt TestGNA · Traditional Pharmacia, Inc.09/02/1988SE
K855234Diagnostic Reagent Vet-RplaGNA · Traditional Oxoid U.S.A., Inc.11/04/1986SE

Recalls

RecallProductFirmInitiated
Z-1033-2017 Class IIPREMIER EHEC and PREMIER EHEC Bulk.Internal testing has demonstrated that the indicated kit lots produce false positive results when tested… Meridian Bioscience Inc11/08/2016Terminated