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

OAH · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3740

Classification

FDA Product Code: OAH
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 866.3740
Review panel: MI
Medical specialty: Microbiology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

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.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown