C. Difficile Nucleic Acid Amplification Test Assay

OMN · Class I — Low Risk (general controls) · Microbiology · 21 CFR 866.2660

Classification

FDA Product Code: OMN
Device class: Class I — Low Risk (general controls)
Regulation: 21 CFR 866.2660
Review panel: MI
Medical specialty: Microbiology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

In vitro diagnostic test for the qualitative detection of toxigenic clostridium difficile nucleic acids isolated and purified from stool specimens obtained from symptomatic patients.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 5

Source

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