Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

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

Classification

FDA Product Code: PTJ
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

Qualitative detection of carbapenemase enzymes in pure colonies of Enterobacteriaceae and Pseudomonas aeruginosa that have elevated MIC values to any Carbapenem

Market data

Cleared 510(k) submissions: 3
Registered establishments: 3

Source

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