Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus

NXX · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.3700

Classification

FDA Product Code: NXX
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 866.3700
Review panel: MI
Medical specialty: Microbiology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

The s. Aureus pna fish is a qualitative nucleic acid hybridization assay intended for presumptive identification of staphylococcus aureus from blood cultures with gram-positive cocci in clusters (gpcc). This device is not exempt per 21 cfr part 866.9(c)(6).

Market data

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

Source

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