System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen

NQX · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.1640

Classification

FDA Product Code: NQX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.1640
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A nucleic acid amplification assay system (including probes, other reagents, and instrumentation) is an aid in the identification of MRSA colonization status for the prevention and control of MRSA infections in healthcare settings.

Market data

Cleared 510(k) submissions: 24
Registered establishments: 12

Source

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