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Antigens, All Types, Escherichia Coli

FDA product code GMZ · Class 1 · Microbiology

315

Registered devices

1

Adverse events

2

Recalls

14

510(k) clearances

Devices with this code

E. coli reference strain O153 — Ssi Diagnostica A/S E. coli reference strain K45 — Ssi Diagnostica A/S E. coli reference strain O78 — Ssi Diagnostica A/S E. coli reference strain O98 — Ssi Diagnostica A/S E. coli reference strain O32 — Ssi Diagnostica A/S E. coli reference strain K27 — Ssi Diagnostica A/S E. coli reference strain K34 — Ssi Diagnostica A/S E. coli reference strain K8 — Ssi Diagnostica A/S E. coli reference strain O23 — Ssi Diagnostica A/S E. coli reference strain O75 — Ssi Diagnostica A/S E. coli reference strain O121 — Ssi Diagnostica A/S E. coli reference strain O173 — Ssi Diagnostica A/S E. coli reference strain H56 — Ssi Diagnostica A/S E. coli reference strain K32 — Ssi Diagnostica A/S E. coli reference strain H6 — Ssi Diagnostica A/S E. coli reference strain K54 — Ssi Diagnostica A/S E. coli reference strain O132 — Ssi Diagnostica A/S E. coli reference strain O69 — Ssi Diagnostica A/S E. coli reference strain K18ab — Ssi Diagnostica A/S E. coli reference strain O135 — Ssi Diagnostica A/S E. coli reference strain O171 — Ssi Diagnostica A/S E. coli reference strain O2 — Ssi Diagnostica A/S E. coli reference strain K84 — Ssi Diagnostica A/S E. coli reference strain H32 — Ssi Diagnostica A/S

Recent recalls

Date	Firm	Reason
2006-08-21	Hardy Media Inc Dba Hardy Diag	Performance failure; the product is failing to show pigment development for E. coli 0157.
2002-07-18	Remel, Inc.	A potential contamination was noted in the conjugate in the ProSpecT Shiga Toxin E. coli Microplate Assay. The particulate in the conjugate may cause the dropp

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.