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Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis

FDA product code OAH · Class 1 · Microbiology

0
Registered devices
0
Adverse events
1
Recalls
4
510(k) clearances

Recent recalls

DateFirmReason
2010-06-08AdvanDx, Inc.Some strains of streptococus anginosus cross-reach with E. faecalis/OE PNA FISH to produce a false positive green signal.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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