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

FDA product code OAH · 4 cleared devices

Class 1 Microbiology
Regulation
21 CFR 866.3740
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2006-12-22 – 2013-01-07

E. Faecalis pna fish is a qualitative nucleic acid hybridization assay intended for the identification of enterococcus faecalis and other enterococci (oe) from blood cultures showing Gram-positive cocci in pairs and chains.

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