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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 K54 — Ssi Diagnostica A/S E. coli OKO 45 reference strain — Ssi Diagnostica A/S E. coli reference strain O129 — Ssi Diagnostica A/S E. coli reference strain K33 — Ssi Diagnostica A/S E. coli reference strain H18 — Ssi Diagnostica A/S E. coli reference strain H20 — Ssi Diagnostica A/S E. coli reference strain K37 — Ssi Diagnostica A/S E. coli reference strain O164 — Ssi Diagnostica A/S E. coli reference strain K6 — Ssi Diagnostica A/S E. coli reference strain K30 — Ssi Diagnostica A/S E. coli reference strain O83 — Ssi Diagnostica A/S E. coli reference strain O74 — Ssi Diagnostica A/S E. coli reference strain O123 — Ssi Diagnostica A/S E. coli reference strain K93 — Ssi Diagnostica A/S E. coli reference strain O168 — Ssi Diagnostica A/S E. coli reference strain O181 — Ssi Diagnostica A/S E. coli reference strain O28ac — Ssi Diagnostica A/S E. coli reference strain H34 — Ssi Diagnostica A/S E. coli reference strain O141ac — Ssi Diagnostica A/S E. coli reference strain K31 — Ssi Diagnostica A/S E. coli reference strain O8 — Ssi Diagnostica A/S E. coli reference strain K92 — Ssi Diagnostica A/S E. coli reference strain K83 — Ssi Diagnostica A/S E. coli reference strain O136 — 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.