System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture

QBQ · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.2560

Classification

FDA Product Code: QBQ
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 866.2560
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Qualitative, in vitro diagnostic system that monitors microbial growth directly from normally sterile body fluid sample incubated in a liquid culture medium

Market data

Cleared 510(k) submissions: 1
Registered establishments: 0

Source

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